FDA updates on hand sanitizers consumers should not use
This page is no longer being updated. Visit the drug recalls page or search FDA’s recalls database for additional hand sanitizer recalls. You also can find information on inspections and other FDA actions on the data dashboard.
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Hand sanitizers consumers should not use
FDA urges consumers not to use certain hand sanitizer products
One of the best ways to prevent the spread of COVID-19 or other diseases are to wash your hands with soap and water. If soap and water are not available, the Centers for Disease Control and Prevention recommends using an alcohol-based hand sanitizer that contains at least 60% ethanol (also known as ethyl alcohol).
Visit Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? and Safely Using Hand Sanitizer for more information.
How to identify hand sanitizer products you should not use:
- The names of the specific manufacturers.
- NDC number, which may also be located on the product label.
- The name of the distributors that sell, or sold or had planned to sell specific hand sanitizers products produced by these manufacturers.
If the manufacturer is not listed on the label, contact the distributor to find out who manufactured the product. If the distributor refuses to clarify this information when you contact them, FDA recommends you do not use the product.
FDA recognizes that distributors may use more than one manufacturer to produce their hand sanitizer products even if they are marketed under the same brand name. FDA’s recommendation not to use a manufacturer specific hand sanitizer would not necessarily extend to all products under that specific distributor brand name or other products sold by that distributor.
How to use the table below:
- Using the information on the hand sanitizer label, type one of the following in the search box:
- Product or brand name
- Manufacturer, or the company that produced the product (may not be included on the product label)
- Distributor, the company that brings the product to market
- NDC or National Drug Code number (may not be included on the product label)
- Do not use any hand sanitizer made by manufacturers on the list.
| Manufacturer | Product(s) | NDC(s) | Distributor | Product Status | Date added to table |
|---|---|---|---|---|---|
| Aruba Aloe Balm Inc. (Aruba) | Aruba Aloe Hand Sanitizer 80% Alcohol | 53675-185-12 53675-192-02 |
Aruba Aloe of North America LLC (Indiana) | Product contains methanol based on information provided by the manufacturer; product voluntarily recalled on 4/5/2024 | 04/17/2024 |
| Aruba Aloe Balm Inc. (Aruba) | Aruba Aloe Hand Sanitizer Spray 80% Alcohol | 53675-193-02 53675-193-08 |
Aruba Aloe of North America LLC (Indiana) | Product contains methanol based on information provided by the manufacturer; product voluntarily recalled on 4/5/2024 | 04/17/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
75% Alcohol Shierjie |
43116-001-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
75% Alcohol rinse free hand sanitizer Shierjie |
43116-002-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Shierjie Medical Alcohol Wipes |
43116-003-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Shierjie 75% Alcohol Wipes |
43116-020-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Shierjie Disinfecting Soft Wipes |
43116-026-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Salusen Premium 75% Alcohol Disinfectant Wipes |
43116-006-01 |
Procom Products Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Alcohol pads One pad saturated with 75% alcohol |
43116-016-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
WBM Care Natural Aloe Advanced Hand Sanitizer |
43116-007-01 |
WBM USA (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
WBM Care Advanced Hand Sanitizer Natural Aloe |
43116-008-01 |
WBM USA (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
WBM Care Advanced Hand Sanitizer Lemon & Orange |
43116-009-01 |
WBM USA (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
XEPA Antibacterial Hand Wipes |
43116-010-01 |
Apex Enterprise Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
75% Alcohol Hand Sanitizer Gel |
43116-015-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Shierjie Alcohol Wipes |
43116-018-01 |
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
75% Alcohol Antibacterial Hand Wipes |
43116-021-02 |
Grocery Outlet Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Necessities Antibacterial Wipes Aloe Vera |
43116-021-01 |
PK Douglass (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
XS Alcohol Prep Pad |
43116-022-01 |
XS-Supply (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
XS Wipes 75% Alcohol Wipes |
43116-025-01 |
XS-Supply (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
|
Shenzhen Shierjie Biological Engineering Co. Ltd. (China) |
Alcohol Antiseptic Hand Sanitizer Antibacterial |
43116-030-01 |
Custom Quest (Ohio) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
| Shenzhen Shierjie Biological Engineering Co. Ltd. (China) | Viloe 75% Alcohol Hand Sanitizer Wipes | 43116-281-40 | Sonora Corp. (California) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 |
02/21/2024 |
| Lydia Co. Ltd. (Korea) | Hand & Care Clear Gel | 72988-0024-1 | Unknown | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024 | 02/21/2024 |
|
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China) |
Kentex Instant Hand Sanitizer with Aloe Vera |
69556-333-02 |
Kentron Healthcare, Inc. (Tennessee) |
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality. |
01/10/2024 |
|
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China) |
Kentex Hand Sanitizing Wet Wipes |
69556-444-80 |
Kentron Healthcare, Inc. (Tennessee) |
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality. |
01/10/2024 |
|
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China) |
Medical Mary Clean Hand Gel Sanitizer |
73027-101-06 |
Medical Mary, LLC (Michigan) |
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality. |
01/10/2024 |
|
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China) |
Fresh Basics + Disinfectant Gel |
73027-106-01 |
3B International LLC |
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality. |
01/10/2024 |
|
Hygienic Labs, LLC. |
KleenSwell Liquid Hand Sanitizer |
79692-002-01 |
Hygienic Labs, LLC. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/19/2023. |
11/08/2023 |
|
Hygienic Labs, LLC. |
KleenSwell Gel Hand Sanitizer with Aloe |
79692-003-01 |
Hygienic Labs, LLC. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/19/2023. |
11/08//2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft Advanced Formula Hand Sanitizer |
74955-020-17 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Soft & Gentle Antibacterial Wet Wipes |
74955-021-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Hand Cleaning Spray Antibacterial Hand Sanitizer |
74955-022-05 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Alcohol Wipes Containing 70% Antibacterial Plus Hygiene |
74955-027-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft Antibacterial Wipes with Alcohol |
74955-028-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft Multipurpose Sanitizing Wipes |
74955-029-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft 75% Alcohol Sanitizing Spray Berry Fresh Scent |
74955-034-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft 75% Alcohol Sanitizing Spray Citrus Fresh Scent |
74955-035-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft 75% Alcohol Sanitizing Spray Crisp Linen Fresh |
74955-036-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Breeze Extra Soft 75% Alcohol Sanitizing Spray Ocean Fresh Scent |
74955-037-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Natural Sense 75% Alcohol Wipes Lemon Scent |
74955-038-02 |
IGT Group (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Quick Protect Sanitizing Spray Linen Fresh |
74955-039-02 |
Premier Wholesale (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi |
Naturally Antibacterial Wet Wipes Formulated to Include Aloe Vera |
74955-040-01 |
UNAC International Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/08/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Original |
52862-606-08 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Cucumber Melon |
52862-607-08 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Sweet Pea |
52862-608-08 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Lavender |
52862-609-08 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Peach |
52862-610-08 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Health Smart Wet Wipes Antibacterial for Hands & Face |
52862-611-10 |
Homesmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Germ Out Fresh Scent Antibacterial Wet Wipes |
72308-015-20 |
Flex Beauty Labs, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Visibly Clean Antibacterial Wet Wipes Blue Sage Lime |
72308-036-00 |
Flex Beauty Labs, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Visibly Clean Antibacterial Wet Wipes Strawberry Tart |
72308-037-00 |
Flex Beauty Labs, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Visibly Clean Antibacterial Wet Wipes Fresh Lemonade |
72308-038-00 |
Flex Beauty Labs, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Bittol Anti-Bacterial Wet Wipes |
78564-000-01 |
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Bittol Anti-Bacterial Hand Gel |
78564-001-01 |
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Bittol Anti-Bacterial Hygienic Hand Cleaning Liquid |
78564-003-01 |
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Bittol Alcohol Wipes |
78564-004-01 |
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Ten Wet Wipes Antibacterial for Hands & Face |
78564-006-10 |
COSCA Inc (Puerto Rico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi |
Antibacterial Colmerg Hand Sanitizing Wipes |
80171-001-00 |
Colmerg Products LLC (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023. |
11/01/2023 |
|
Gulf States International, Inc. |
Brittanie’s Thyme Rosemary and Peppermint Hand Sanitizer |
76473-100-01 |
Brittanie’s Thyme, LLC (Alabama) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023. |
11/01/2023 |
|
Gulf States International, Inc. |
Brittanie’s Thyme Orange and Peppermint Hand Sanitizer |
76473-101-01 |
Brittanie’s Thyme, LLC (Alabama) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023. |
11/01/2023 |
|
Gulf States International, Inc. |
Brittanie’s Thyme Lemongrass and Peppermint Hand Sanitizer |
76473-102-01 |
Brittanie’s Thyme, LLC (Alabama) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023. |
11/01/2023 |
|
Gulf States International, Inc. |
Brittanie’s Thyme Lavender and Peppermint Hand Sanitizer |
76473-103-01 |
Brittanie’s Thyme, LLC (Alabama)
|
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023. |
11/01/2023 |
|
Gulf States International, Inc.
|
Brittanie’s Thyme Gel Hand Sanitizer |
76473-104-01 |
Brittanie’s Thyme, LLC (Alabama)
|
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023. |
11/01/2023 |
|
Maison Blanche LLC (Texas) |
Hand Sanitizer N°93 Maison Blanche Eucalyptus & Coconut Oil |
78966-111-11 |
Maison Blanche LLC (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/14/2023. |
10/11/2023 |
|
WIPRO Consumer Care Vietnam Co. Ltd. (Vietnam) |
Aiken Hand Sanitizer |
75651-172-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan) |
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads |
71490-001-02 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan) |
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads |
71490-015-03 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan) |
HiGeen Gold Antiseptic Hand Sanitizer Gel with Vitamin Beads |
71490-029-03 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan) |
HiGeen Antiseptic Hand Sanitizer Gel |
71490-039-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan) |
HiGeen Antiseptic Hands & Things Sanitizer Spray |
71490-043-08 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
GTP International Corp. (Texas) |
Green Beauty Advanced Hand Sanitizer |
79347-000-01 |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 08/30/2023. |
08/30/2023 |
|
Cergomex Imports, LLC (Texas) |
Sanetto Hands Sanitizer Gel |
81101-200-02 |
Cergomex Imports, LLC (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 08/04/2023. |
08/30/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
First Safety Instant Hand Sanitizer Wipes (70% Alcohol) |
74763-002-01 |
First Safety (Massachusetts) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
Responsible Hand Sanitizer Advanced Moisturizing Formula With Vitamin E |
74763-003-01 |
Clover Imaging Group (Illinois) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
OmegaClean Alcohol Wipes |
74763-005-01 |
JAS Supply (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
First Safety Instant Hand Sanitizer Wipes (75% Alcohol) |
74763-013-01 |
First Safety (Massachusetts) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
AltruFuel Sanitizer Wipes (75% Alcohol) |
74763-014-01 |
Altrufuel dba Mad Dog Concepts, LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
Miami Carry On Disinfecting & Sanitizing 75% Alcohol Wipes |
74763-018-01 |
Naftali Inc. (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
M Antibacterial Hand Gel Packs |
74763-019-01 |
Mytagalongs (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
DefendMax Hand Sanitizer (75% Alcohol) |
78256-102-01 |
DefendMax (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
PuraHands Hand Sanitizer |
78256-104-02 |
PuraHands (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
Miami Carry On Instant Hand Sanitizer With Vitamin E |
74763-012-01 |
Naftali Inc. (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
Gafle Hand Sanitizer Gel with moisturizer |
74763-001-01 |
Zhejiang Gafle Auto Chemical Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi |
ALLPURE Hand Sanitizer with Soothing Aloe Vera Natural 70% Alcohol |
78575-002-01 |
CERCI USA Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/23/2023 |
|
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi |
DEVANIT Hand Sanitizer Natural 70% Alcohol Antiseptic with Soothing Aloe Vera |
78575-001-01 |
CERCI USA Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/23/2023 |
|
Planet Luxe Operations Pty, Ltd. |
Planet Luxe Hand Sanitizer |
81109-000-50 |
Planet Luxe Operations Pty, Ltd. (Australia) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/23/2023 |
|
Absolut Distillers, Ltd. |
ALCOGENIX Alcohol |
90046-503-01 |
Midway Trading Corporation (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/23/2023 |
|
Leads China Biotech Co., Ltd. (China) |
Myxx Antibacterial Hand Sanitizer |
72619-2020-1 72619-2020-2 72619-2020-4 77969-004-01 77969-004-02 |
Accessory Myxx LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to Import alert to help stop their products from entering the U.S. on 09/14/2023. |
08/23/2023 |
|
Leads China Biotech Co., Ltd. (China) |
Hand Sanitizer Contains 70% Ethyl Alcohol Topical Solution |
75624-123-01 75624-123-02 75624-123-03 75624-123-04 75624-123-05 75624-123-06 |
SCAASIS/Oceanic Trading (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/14/2023. |
08/23/2023 |
|
Leads China Biotech Co., Ltd. (China) |
Lovemee Hand Sanitizer |
77969-001-01 77969-001-02 77969-001-04 77969-001-05 77969-001-06 77969-001-07 77969-001-08 77969-001-09 |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Leads China Biotech Co., Ltd. (China) |
Doc Hygiene Hand Sanitizer Spray |
77969-003-01 |
Doc Hygiene |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Leads China Biotech Co., Ltd. (China) |
Doc Hygiene Hand Sanitizer Extra Strength |
77969-002-01 77969-002-02 78765-001-01 79508-010-01 79508-010-02 79508-010-03 |
Doc Hygiene |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023. |
08/23/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
Antibacterial Hand Wipes |
77765-000-01 |
Sam Hedaya Corp. (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
Pura Wipes (75% Alcohol) |
77765-001-00 |
Zaappaaz LLC (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
XcellaClean 75% Alcohol Disinfectant Wipes |
77765-012-01 |
Ningbo Unice Houseware Co., Ltd (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
XcellaClean Mild antibacterial formula Disinfectant Wipes |
77765-013-01 |
Ningbo Unice Houseware Co., Ltd (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
DailyGard Wipes Ethyl Alcohol 75% |
77765-014-01 |
OlleyMay (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
DailyGard Wet Wipes |
77765-015-01 |
Carity USA LLC (Delaware) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
DailyGard Wipes Ethyl Alcohol 75% |
77765-011-01 |
Candy Brush LLC (Nevada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
DailyGard Wipes 75% Ethyl Alcohol |
78198-004-01 |
Creative Home Ideas (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Hangzhou Beitai Daily Commodity Co., Ltd. |
DailyGard Wipes 75% Isopropyl Alcohol |
78198-005-01 |
Creative Home Ideas (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023. |
08/16/2023 |
|
Amata Life Plus Co., Ltd. |
Clean Day Antiseptic |
80167-070-01 |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/31/2023. |
08/16/2023 |
|
Prenger Furniture Inc. |
PFI Hand Sanitizer 80% Alcohol |
74667-001-01 |
Unknown |
FDA tested product; contains unacceptable level of acetal and acetaldehyde contaminants; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination. |
08/02/2023 |
|
Farmacos Bioequivalentes, S.A., dba: Biopharma |
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer |
79492-000-01 |
In & Out Products & Services (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/02/2023 |
|
Farmacos Bioequivalentes, S.A., dba: Biopharma |
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer |
79492-000-02 |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/02/2023 |
|
Farmacos Bioequivalentes, S.A., dba: Biopharma |
Ethyl 80% Alcohol Solution (Ethyl Alcohol 80%) |
79492-001-01 |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality |
08/02/2023 |
|
Farmacos Bioequivalentes, S.A., dba: Biopharma |
Isopropyl Alcohol (ANTI-INFECTIVE, TOPICAL) Hand Sanitizer |
Unable to determine |
Unknown |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
08/02/2023 |
|
Penseur Kreativa Group |
CARE HAND |
81227-000-01 |
Penseur Kreativa Group |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Penseur Kreativa Group |
PENSEUR GROUP |
81227-002-00 |
Penseur Kreativa Group |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Penseur Kreativa Group |
GO GERMS OUT |
81227-001-00 |
Penseur |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
|
Penseur Kreativa Group |
VPBIOMED Antiseptic |
81227-008-00 |
Paola Enterprises para |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
07/05/2023 |
| Beattie’s Distillers Inc (Canada) |
Beattie’s Distillers Hand Sanitizer |
77427-7427-7 |
Beattie’s Distillers Inc (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
06/21/2023 |
|
Beattie’s Distillers Inc |
Beattie’s Distillers Hand Sanitizer Liquid 80% Alcohol |
77427-7444-4 |
Beattie’s Distillers Inc (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
06/21/2023 |
|
Beattie’s Distillers Inc |
Beattie’s Distillers Hand Sanitizer Gel Formula |
77427-6311-5 |
Beattie’s Distillers Inc (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
06/21/2023 |
|
Classic Wine Vinegar Company, Inc. |
Absolved Hand Sanitizer |
75600-807-01 |
Not listed |
FDA tested product; contains unacceptable level of acetal contaminant; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination |
06/21/2023 |
|
Classic Wine Vinegar Company, Inc. |
Absolved Hand Sanitizer |
75600-807-50 |
Entral Product Solutions (California) |
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination |
06/21/2023 |
|
Classic Wine Vinegar Company, Inc. |
Hand Sanitizer Liquid |
79117-070-01 |
Emerge Technologies, Inc. (Texas) |
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Sierra Soft Alcohol hand sanitizer |
70415-002-01 |
Sierra Health Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Royal 70% Alcohol Foam Hand Sanitizer |
70415-202-01 |
Royal Papers, Inc. (Missouri) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Fresh Hand Foaming Hand Sanitizer Alcohol Foam |
70415-203-11 |
Resource Solutions of SF Group, Inc (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Hand Hygiene Puro 70% Alcohol Foaming Hand Sanitizer |
70415-402-01 |
Sierra Health, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Delicare Alcohol Hand Sanitizer |
70415-601-11 |
SML Medical Supplies, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
HYTN Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer |
74871-052-00 |
iTech361 LLC (New Mexico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
PPE 361 Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer |
74871-053-00 |
iTech361 LLC (New Mexico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
HYTN 75% Alcohol Multipurpose Wipes |
74871-081-00 |
iTech361 LLC (New Mexico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Raw Instant Hand Sanitizer Gel |
75353-614-50 |
The Raw Office Inc. (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Altrufuel advanced formula With Aloe Vera Hand Sanitizer |
75421-000-00 |
Mad Dog Concepts, LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Altrufuel advanced formula With Vitamin E + Aloe Vera Hand Sanitizer |
75421-001-00 |
Mad Dog Concepts, LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Physicians Wellness Products Hand Sanitizer Alcohol Antispetic 75% |
76591-001-01 |
Physician’s Wellness Group Inc (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Rinse-free Hand Sanitizer |
76591-101-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer |
76591-201-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer |
76591-301-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.99% Gel Alcohol Hand Sanitizer |
76591-401-01 |
Guangzhou Gotdya Fine Chemical Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Halloween Party Favors Hand Sanitizer |
76591-402-01 |
Walmart Inc. (Arkansas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.99% Spray Alcohol Hand Sanitizer |
76591-501-01 |
Guangzhou Gotdya Fine Chemical Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Gotdya Bacteriostatic Rate 99.99% Disposable Alcohol 75% Alcohol Antiseptic Wipes |
76591-601-01 |
Guangzhou Gotdya Fine Chemical Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
CenterWell Bacteriostatic Rate 99.9% Spray Alcohol Hand Sanitizer |
76591-701-01 |
Guangzhou Gotdya Fine Chemical Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Maxda Care Alcohol Gel Hand Sanitizer |
76591-801-01 |
Vertriebs GmbH (Germany) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
LIFEMEDZ Hand Sanitizer |
78500-100-30 |
LIFEMEDZ LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
LIFEMEDZ Rinse-Free Hand Sanitizer |
78500-101-30 |
LIFEMEDZ LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Miracle Brands Touchless Dispenser Hand Sanitizer |
80352-001-01 |
Miracle Brands, LLC (Arizona) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Miracle Brands Hand Sanitizer Refill Bottle |
80352-002-01 |
Miracle Brands, LLC (Arizona) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Sanibeads Hand Sanitizer Filled Bracelet |
80627-001-01 |
Sanibeads, LLC (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
Guangzhou Gotdya Fine Chemical Co., Ltd. |
Tego Systems Professional Grade Hand Sanitizer |
81497-700-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/21/2023 |
|
IBC Business COOP |
Young Living Thieves Waterless Hand Sanitizer |
70631-577-03 |
Young Living Essential Oils, LC. (Utah) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/07/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Toasted Vanilla Sweet & Shimmer Antibacterial Hand Sanitizer Spray |
62651-015-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Sparkling Rose Sweet & Shimmer Antibacterial Hand Sanitizer Spray |
62651-016-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Sweet and Shimmer Gum Drop Hand Sanitizer |
62651-024-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Sweet and Shimmer Pepper Mint Hand Sanitizer |
62651-025-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Sweet and Shimmer Sugar Cookie Hand Sanitizer |
62651-026-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Sweet and Shimmer Sweet Pomegranate Hand Sanitizer Spray |
62651-027-01 |
Base4 Ventures (Texas) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Pharmacy’s Prescription Instant Hand Sanitizer with Moisturizers & Vitamin E |
73597-007-08 |
Prestige Beauty Care (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Beauty Formation Alcohol Antiseptic 80% Topical Solution Hand Sanitizer |
74430-001-08 |
Beauty Formation |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Living Essentials Corp. Hand Sanitizer Advanced Formula |
74430-002-08 |
Pacific Bridge Products, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
TCM Advanced Hand Sanitizer with Aloe |
74430-003-02 |
Tradecom Int. Inc. (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Rinse-Free Hand Sanitizer Soothing Gel 70% Alcohol Antiseptic |
74430-004-16 |
Blakemore Sales Corp (Missouri) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Bloom Health Antibacterial Hand Sanitizer |
74430-005-02 |
Magnet Fragrance |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Nevada National Products Antibacterial Hand Sanitizer Aloe Vera |
74430-007-02 |
Nevada Group, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer with Aloe |
74430-010-01 |
Tash Market Place |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer with Aloe |
74430-010-02 |
Watson |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer with Aloe |
74430-010-03 |
Beauty Formation |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer |
74430-011-01 |
Tash Market Place |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer |
74430-011-02 |
Watson |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Watson Hand Sanitizer |
74430-011-03 |
Beauty Formation |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Beauty Formation Instant Hand Sanitizer |
74430-013-01 |
Beauty Formation |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Element Control Rinse-Free Hand Sanitizer Soothing Gel |
74430-014-01 |
Strategic Orient Sourcing Limited (Hong Kong) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
Yuyao Huanyan Daily Chemical Products Co., Ltd. |
Living Essentials Corp Hand Sanitizer |
74430-015-59 |
Living Essentials Corp. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023. |
06/21/2023 |
|
EASTLAB Inc. |
Aube Hand Sanitizer with Rich Moisture |
76656-100-01 |
K Boom Beauty, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangzhou Da’ao Cosmetics Co., Ltd. |
Plant Grow Disposable Hand Sanitizer |
52965-001-01 |
Not listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangzhou Da’ao Cosmetics Co., Ltd. |
Germ Shark Antibacterial Hand Sanitizer |
75158-500-06 |
Germ Shark LLC |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangzhou Da’ao Cosmetics Co., Ltd. |
CJG Instant Hand Sanitizer |
77372-004-00 |
CJ Global Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangzhou Da’ao Cosmetics Co., Ltd. |
Hand Sanitizer Gel |
52965-010-01 |
Love 2 Design LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangzhou Da’ao Cosmetics Co., Ltd. |
Hand Sanitizer |
75758-001-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. |
VizoCare Soothing Gel Hand Sanitizer |
79805-001-01 |
Vizocom ICT LLC (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. |
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%) |
79805-002-01 |
Aldi (Illinois) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. |
VizoCare Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%) |
79805-002-02 |
Vizocom ICT LLC (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. |
GoldEssence Wellness Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%) |
79805-002-03 |
Goldessence Limited (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. |
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.13%) |
79805-011-01 |
Aldi (Illinois) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Juxin (Jiangsu) New Material Packing Co., Ltd. (China) |
Omega Clean Sanitizing Wipes |
79805-010-01 |
JAS Supply, Inc. (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Kolts Fine Spirits |
Hand Sanitizer KOLTISKA K DISTILLERY Alcohol 80% Topical Solution |
74244-0001-1 |
Koltiska Distillery |
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
BeSafe Hand Sanitizer |
77693-001-01 |
BeSafe Industries, LLC (Florida) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
1Source Advanced Hand Sanitizer Refreshing Gel |
77871-001-01 |
AVS Energy, Inc. (Georgia) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
1Source Advanced Hand Sanitizer Liquid Foam |
77871-002-01 |
AVS Energy, Inc. (Georgia) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
5Seconds Advanced Hand Sanitizer Liquid Foam |
77871-005-01 |
AVS Energy, Inc. (Georgia) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
5Seconds Advanced Hand Sanitizer Refreshing Gel |
77871-004-01 |
AVS Energy, Inc. (Georgia) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
U Instant Hand Sanitizer Classic |
75112-006-01 |
Universal Distribution Center (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
U Instant Hand Sanitizer Aloe Vera |
52000-115-03 |
Universal Distribution Center (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
SPIRITZ IT 2 in 1 Pen with Hand Sanitizer |
75112-008-01 |
DMM (Illinois) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
Rilakkuma Aloe Vera Scented Hand Sanitizer |
75112-009-01 |
Aliquantum International, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
Yixin Sunlin Instant Hand Sanitizer |
75112-001-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
Yixin Sunlin Instant Hand Sanitizer |
75112-005-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
SUDESAN Hand Sanitizer Original |
75112-002-01 |
XM Wholesale (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
Health Smart Instant Hand Sanitizer |
75112-003-01 |
HomeSmart Products (Michigan) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
Zhejiang Shenying Technology Co., Ltd. |
Healing Solutions Premium Hand Sanitizer |
75112-004-01 |
Healing Solutions, LLC (Arizona) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023. |
06/07/2023 |
|
EASTLAB Inc. |
D6 Plants Hand Sweeper (70% Alcohol) |
76656-101-01 |
K Boom Beauty, Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
06/07/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
Disinfectant Gel Advanced Formula (75% alcohol) |
76714-001-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
Disinfectant Gel Advanced Formula (75% alcohol) |
76714-001-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
Korusa 75% Alcohol Hand Sanitizer Gel |
76714-001-02 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
CB Advanced Hand Sanitizer |
76714-001-04 |
CB Distributors, Inc. (Wisconsin) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
Dew’s Plus Disinfectant Gel Hand Sanitizer |
76714-001-06 |
Magic Trade INC (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
AuraFresh Kids Hand Sanitizer |
76714-001-07 |
TopGrade Products Inc (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
Disinfectant (75% alcohol) |
76714-002-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
AuraFresh 75% Alcohol Spray Disinfectant & Antimicrobial |
76714-002-03 |
TopGrade Products Inc (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guangdong Yawei Bioscience Co Ltd. |
AuraFresh 75% Alcohol Ethyl Rubbing Alcohol |
76714-002-05 |
TopGrade Products Inc (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd. |
Alcohol-Based Disinfectant Hand Sanitizer Gel (75% alcohol) |
74757-001-01 |
ATZ Med Supply (Maryland) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd. |
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel |
79606-001-01 |
LiveLife Corp. (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd. |
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel |
79606-002-01 |
LiveLife Corp. (Canada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Shandong Oushile Biotechnology Co., Ltd. |
Lifeguard Multi Purpose Antiseptic Alcohol Wipes |
77879-003-01 |
Not Listed |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Shandong Oushile Biotechnology Co., Ltd. |
Pro Clean Hand Sanitizer |
78781-311-10 |
Bigbattery Inc (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Shandong Oushile Biotechnology Co., Ltd. |
Blue Unity 75% Alcohol Wet Wipes |
78781-080-50 |
RIXI Group USA Inc (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023. |
05/31/2023 |
|
Yiwu Mango Cosmetics, Ltd. |
Instant Hand Sanitizer (Alcohol 75%) |
76824-001-01 |
Yiwu Mango Cosmetics, Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 6/12/2023. |
05/24/2023 |
|
Laavo Clean, S.A. de C.V. |
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 3790mL |
80806-520-02 |
Laavo Clean, S.A. de C.V. |
FDA tested product; benzalkonium chloride level was subpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023. |
05/17/2023 |
|
Laavo Clean, S.A. de C.V. |
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 60mL |
80806-520-03 |
Laavo Clean, S.A. de C.V. |
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023. |
05/17/2023 |
|
Laavo Clean, S.A. de C.V. |
Kids Instant Hand Sanitizer (Benzalkonium Chloride 0.13%) |
80806-510-01 |
Laavo Clean, S.A. de C.V. |
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023. |
05/17/2023 |
|
Haining Twowell Daily Commodity Co., Ltd. |
Activa Hand Sanitizer Wipes |
80552-001-01 |
Blue Ribbon Supply Company |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 05/22/2023. |
05/03/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd |
Mayseen Instant Hand Sanitizer |
78565-016-01 |
Skyelee Inc |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023 |
04/26/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd |
Vivitar Advanced Hand Sanitizer |
Unspecified |
Sakar International |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023 |
04/26/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd |
Healing Solutions Premium Hand Sanitizer |
Unspecified |
Healing Solutions LLC |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023 |
04/26/2023 |
|
Natuurs Direct, LLC |
Natuurs Advance Hand Sanitizer Alcohol Antiseptic 80% |
75393-4800-5 |
Natuurs Direct, LLC |
Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of contamination. |
04/19/2023 |
|
Natuurs Direct, LLC |
Natuurs Pure Liquid Sanitizer Hand & Surface Alcohol Antiseptic 80% |
Not listed |
Natuurs Direct, LLC |
FDA tested product; contains acetaldehyde and acetal contaminants; Company did not adequately respond to FDA requests for records and other information related drug manufacturing, product quality and scope of the contamination. |
04/19/2023 |
|
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota) |
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution |
74663-001-04
|
MCS Midwest Cleaning Solutions (South Dakota) |
FDA tested product; contains unacceptable levels of methanol; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023. |
04/12/2023 |
|
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota) |
Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution |
74663-002-04 |
MCS Midwest Cleaning Solutions (South Dakota) |
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023. |
04/12/2023 |
|
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota) |
SOFT HANDS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution |
77518-200-01
|
Clean Pro Supply, LLC (New York) |
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
Macy’s Antibacterial Hand Sanitizer Gel (75% ethyl alcohol) |
Unspecified |
MiWorld Accessories, LLC. (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
Isaac Mizrahi New York Hand Sanitizer |
Unspecified |
MWA, LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
C Wonder Hand Sanitizing Spray |
Unspecified |
MWA, LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
L+W Bio Hygienic Hand Sanitizer |
78713-002-08 |
Luxe + Willow / MWA (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
C Wonder Sanitizing Gel |
Unspecified |
MiWorld Accessories LLC (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
Sanitize Keep Hands Clean Luxe + Willow Hand Sanitizer |
Unspecified |
Luxe + Willow / MWA (New York) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
|
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China) |
Lifeguard Hand Sanitizer |
Unspecified |
Lifeguard (Nevada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023. |
04/12/2023 |
| Labisco Corporation (South Korea) |
Dr. Days V-CIDER Hand Clean Gel | 75535-0003-1 | Labisco Corporation (South Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/14/2023. | 04/05/2023 |
| Labisco Corporation (South Korea) |
Dr. Day Hand Clean Gel | 75535-0001-1 75535-0002-1 |
Labisco Corporation (South Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/14/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
CB Advanced Hand Sanitizer | 74935-005-00 74935-014-00 76813-005-00 76813-014-00 73529-353-01 |
CB Distributors Inc. (Wisconsin) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Steel Hand Sanitizer Disinfectant Spray | 79931-001-01 | Steel Supplements Inc. (Florida) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Pro-Tex Instant Hand Sanitizer | 52728-020-01 | GoodBuys USA Inc (Texas) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
CB Advanced Hand Sanitizer | 74935-005-00 74935-014-00 76813-005-00 76813-014-00 73529-353-01 |
CB Distributors Inc. (Wisconsin) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Anjieshu Instant Hand Sanitizer | 52728-001-01 52728-002-01 52728-003-01 52728-004-01 52728-005-01 52728-006-01 52728-007-01 52728-008-01 52728-010-01 52728-011-01 52728-012-01 52728-013-01 52728-014-01 52728-015-01 52728-017-01 52728-018-01 52728-019-01 79485-100-10 79485-100-20 79485-100-30 |
TAMSC Inc. (California) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Clever Choice Instant Hand Sanitizer Gel | 62379-006-26 | Simple Diagnostics, Inc. (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Tech 361 Hand Sanitizer with Aloe Vera Extract | 74871-050-00 74871-050-01 74871-060-00 74871-060-01 74871-100-00 74871-100-01 |
iTech 361 LLC (New Mexico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
HYTN Hand Sanitizer with Aloe Vera Extract | 74871-051-00 74871-051-01 74871-061-00 74871-061-01 74871-120-00 74871-120-01 74871-237-00 74871-237-01 74871-500-00 74871-500-01 74871-900-00 74871-900-01 |
iTech 361 LLC (New Mexico) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Hand Sanitizer 70% Ethyl Alcohol Aloe & Vitamin E | 77725-001-08 77725-002-01 |
L.E.D Cosmetics Inc. (California) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Quality Choice Instant Hand Sanitizer | 77725-003-02 77725-003-08 77725-003-17 77725-003-33 77725-004-08 |
C.D.M.A. Inc. (Michigan) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
First Step Advanced Hand Sanitizer | 79195-001-01 79195-005-01 79195-006-01 |
First Step Safety Products (California) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Zhejiang Enchant Cosmetic Co., Ltd. (China) |
Healing Solutions Premium Hand Sanitizer | 52728-016-01 77813-001-04 |
Healing Solutions LLC (Arizona) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/20/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
Handy Hand Sanitizer Pocket Spray | 68210-4079-1 68210-4079-2 68210-4079-3 |
Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
Handy Hand Sanitizer Solution with Vitamin E and Moisturizers | 68210-4082-5 | Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
DR. Sanitizer Hand Sanitizer Gel with Vitamin E and Moisturizers | 68210-4081-1 68210-4081-2 68210-4081-5 |
Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
Handy Hand Sanitizer Spray with Vitamin E and Moisturizers | 68210-4077-1 | Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
Handy Hand Sanitizer Gel with Vitamin E and Moisturizers | 68210-4075-1 68210-4075-2 68210-4075-3 68210-4075-4 68210-4075-5 68210-4075-6 68210-4075-7 68210-4075-8 |
Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| Afnan Perfumes, LLC (United Arab Emirates) |
Handy Sanitizer Spray | 68210-4118-3 68210-4118-5 68210-4118-6 |
Spirit Pharmaceuticals, LLC (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/12/2023. | 04/05/2023 |
| BL Cosmetic Co., Ltd (South Korea) |
Mega Clean Hand Sanitizer Liquid | 77799-002-01 | MEGACITY Group, LLC (Florida) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/13/2023. | 04/05/2023 |
| BL Cosmetic Co., Ltd (South Korea) |
Mega Clean Hand Sanitizer | 77799-001-01 77799-057-01 77799-170-01 77799-370-01 77799-570-01 |
MEGACITY Group, LLC (Florida) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/13/2023. | 04/05/2023 |
| BL Cosmetic Co., Ltd (South Korea) |
CEL’RAUM Forest Perfect Hand Cleaner Nonstick gel-type Hand Sanitizer | 75368-010-01 75368-010-02 75368-020-01 75368-020-02 75368-030-01 75368-030-01 |
U&D2 Co., Ltd. (South Korea) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/13/2023. | 04/05/2023 |
| BL Cosmetic Co., Ltd (South Korea) |
Perfect Hand Cleanser | 76645-0001-1 | K INTERNATIONAL Co., Ltd. (South Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/13/2023. | 04/05/2023 |
| Ella Cosmetic Co., Ltd. (South Korea) |
Jasna Pearl Hand Gel Sanitizer | 74003-010-01 74003-020-01 74003-030-01 |
Ella Cosmetic Co., Ltd. (South Korea) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023. | 04/05/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
JM & HFB Disinfection Instant Hand Sanitizer, 75% alcohol |
55028-001-01 |
Zhongshan Dermey Commodity Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
360+ Bio-Lab Advanced Hand Fragrance Free Antimicrobial Gel, 75% alcohol |
55028-011-01 |
Asia Bay, Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
360+ Bio-Lab Advanced Hand Sanitizer Spray, 70% alcohol |
55028-012-01 |
Asia Bay, Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
ShieldOurs Hand Sanitizer Refreshing Gel, 75% alcohol |
55028-015-01 |
Zhongshan Dermey Commodity Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
ProtectorPlus Alcohol Hand Wipes, 75% alcohol |
78378-666-01 |
Cancreativ Packing Corp |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Zhongshan Dermey Commodity Co., Ltd. |
ProtectorPlus Hand Sanitizer, 75% alcohol |
78378-888-01 |
Cancreativ Packing Corp |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023. |
03/22/2023 |
|
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Hand Sanitizer |
75612-030-01 |
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023. |
03/22/2023 |
|
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Instant Hand Sanitizer |
75612-100-01 |
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023. |
03/22/2023 |
|
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Beesoul Instant Hand Sanitizer |
75612-101-01 |
Yiwu Dieyuan Cosmetics Co., Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023. |
03/22/2023 |
|
St. Augustine Distillery LLC |
St. Augustine Distillery Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution |
74324-001-01 |
St. Augustine Distillery LLC (Florida) |
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. |
03/22/23 |
|
Raff Beverage LLC |
Take A Bite Out Of Germs Hand Sanitizer |
74610-008-01 |
Raff Distillerie |
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. |
03/22/2023 |
| Guangzhou Cikang Biotechnology Co., Ltd. (China) | Dr. J’s Natural Advanced Formula Hand Sanitizer | 74416-171-02 74416-171-03 74416-171-04 74416-171-08 74416-171-10 74416-171-16 74416-171-35 74416-172-51 73750-369-01 73750-369-02 73750-369-03 73750-369-04 73750-369-05 73750-369-06 73750-369-07 |
QYK Brands, LLC (California) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 | 03/15/2023 |
|
Guangzhou Yilong Cosmetics Co., Ltd. |
Siruini Hand Sanitizer |
74458-101-01 |
Guangzhou Yilong Cosmetics Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/05/2023. |
03/22/2023 |
|
Guangzhou Yilong Cosmetics Co., Ltd. |
Village Pharma Sanizen Gel Hand Sanitizer (75% alcohol) |
74458-201-01 |
Village Pharma, LLC (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/05/2023. |
03/22/2023 |
|
Guangzhou Meizi Biotechnology Co., Ltd |
Jean Pierre Cosmetics Antibacterial Hand Gel |
79867-002-01 |
Jean Pierre Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 |
03/22/2023 |
|
Guangzhou Meizi Biotechnology Co., Ltd |
Expressions Hand Sanitizer |
79867-001-01 |
Almar Sales Co. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 |
03/22/2023 |
|
Guangzhou Cikang Biotechnology Co., Ltd. |
Smart Care Advanced Hand Sanitizer |
70108-070-01 |
Ashtel Studios Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 |
03/15/2023 |
|
Guangzhou Cikang Biotechnology Co., Ltd. |
Smart Care Hand Sanitizer Aloe Vera & Vitamin E |
70108-038-01 |
Ashtel Studios Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 |
03/15/2023 |
|
Guangzhou Cikang Biotechnology Co., Ltd. |
HiGuys USA Alcohol Disinfectant |
74416-170-01 |
Lancougroup |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023 |
03/15/2023 |
|
Nanomaterials Discovery Corporation |
Snowy Range Blue alcohol antiseptic 80% topical solution |
75288-100-01 |
Reliable Products, LLC |
FDA tested product; contains unacceptable levels of methanol, acetaldehyde and acetal; FDA recommended the company recall on 2/9/2023; product voluntarily recalled on 2/14/2023. |
03/08/2023 |
|
Innovaciones Tecnologicas Concar, SA de CV |
SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%) |
79279-420-01 |
Innovaciones Tecnologicas Concar, SA de CV |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. |
02/22/2023 |
|
Coppercraft Distillery, LLC (Michigan) |
Hand Sanitizer Topical Solution, Alcohol Antiseptic 80% |
75293-001-02 |
Coppercraft Distillery, LLC |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. |
02/22/2023 |
|
Ublendit, Inc. (California) |
Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution |
74515-111 |
Ublendit, Inc. |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. |
02/15/2023 |
|
Dongguan Mingyi Medical Products, Co., Ltd. (China) |
Hand Sanitizer Gel |
74046-001-01 |
Dongguan Mingyi Medical Products, Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023 |
02/01/2023 |
|
Dongguan Mingyi Medical Products, Co., Ltd. (China) |
Hand Sanitizer Spray |
74046-004-01 |
Dongguan Mingyi Medical Products, Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023 |
02/01/2023 |
|
Dongguan Mingyi Medical Products, Co., Ltd. (China) |
Benzalkonium Chloride Instant Hand Sanitizer |
74046-006-01 |
Dongguan Mingyi Medical Products, Co., Ltd. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023. |
02/01/2023 |
|
Drivergent, Inc. (Michigan) |
Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution, |
75037-0001-1 |
Drivergent, Inc. |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023. |
02/01/2023 |
|
Drivergent, Inc. (Michigan) |
Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L) |
Not listed |
Drivergent, Inc. |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023. |
02/01/2023 |
|
Drivergent, Inc., (Michigan) |
Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml) |
Not listed |
Drivergent, Inc. |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023. |
02/01/2023 |
|
Drivergent, Inc. (Michigan) |
Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution |
75037-0002-1 |
Drivergent, Inc. |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023. |
02/01/2023 |
|
Sun Wave Wellness, LLC |
Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent |
75023-0001 75023-0002 75023-0003 75023-0004 75023-0005 |
Sun Wave Wellness, LLC |
FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination. |
01/18/2023 |
|
Frenda Corporation |
Global Care Antibacterial Hand Sanitizer |
74115-001-00 74115-000-00 72146-000-01 72146-020-01 |
Target Price Inc. |
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a warning letter on 02/15/2023. |
12/21/2022 |
|
Frenda Corporation |
Easy Klean Hand Sanitizer |
74115-002-00 |
Frenda Corporation |
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a warning letter on 02/15/2023. |
12/21/2022 |
|
Mohawk Laboratories Division |
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution |
55533-523-01 55533-524-01 55533-524-02 55533-524-03 55533-524-04 |
MULTI-MIST Products |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022. |
12/14/2022 |
|
Ultra Chem Labs, Corp. |
Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer |
79208-001-50 79208-001-32 79208-001-01 |
Ultra Chem Labs |
Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; after FDA recall recommendation, the firm announced a voluntary recall on 10/18/2022; FDA issued a warning letter on 12/20/2022. |
11/16/2022 |
|
Adam's Polishes LLC |
Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Topical Solution |
74943-125-04 74943-125-08 74943-125-16 74943-125-28 |
B&B Blending, LLC, |
FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. |
11/16/2022 |
|
Urban Electric Power |
Ohm Sanitizer Spray 80% alcohol |
774135-564-01 |
Urban Electric Power |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. |
11/09/2022 |
|
Urban Electric Power |
Ohm Hand Sanitizer 70% Alcohol |
74135-001-01 |
Urban Electric Power |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. |
11/09/2022 |
|
Flavor Vapors, LLC, dba: Mob Liquid Labs |
Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution |
75116-075-60 |
Flavor Vapors, LLC |
FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022 |
10/19/2022 |
|
Salon Technologies International |
Salon Technologies International Sanitizing Hand Spray 80% |
76804-001-01 |
Salon Technologies International |
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firm’s testing identified benzene in another product. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. |
10/06/2022 |
|
Salon Technologies International |
Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65% |
76804-009-01 80097-007-01 |
Antica Farmacista |
Company tested product; contains benzene. FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022. |
10/06/2022 |
|
Unibeleza Industria E Comercio De |
Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant |
77457-014-01 77457-015-01 |
Biotipo Brazil |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022 |
09/14/2022 |
|
Venice Cosmetic (Korea) |
Reborncare Hand Sanitizer (100mL, 250mL, 500mL) |
79486-100-01 79486-101-01 79486-102-01 |
Reborncare Co. Ltd |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Venice Cosmetic (Korea) |
Natural Bloom Hand Sanitizer Gel |
78017-100-01 |
Natural Bloom |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Venice Cosmetic (Korea) |
MAY MEDIC Clean Sanitizer gel |
74488-500-01 74488-500-02 |
Venice Cosmetic |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Zorin Pharmaceutical Technology Co. Ltd. (China) |
PEI FAN Instant Hand Sanitizer with Aloe |
75183-006-01 75183-006-02 75183-006-03 75183-006-04 75183-006-05 75183-006-06 75183-006-07 |
Zorin Pharmaceutical Technology Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022 |
09/14/2022 |
|
Zorin Pharmaceutical Technology Co. Ltd. (China) |
Safe Hand Sanitizer with Aloe |
75183-008-01 |
K&B Global Corp |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022 |
09/14/2022 |
|
Zorin Pharmaceutical Technology Co. Ltd. (China) |
Zorari Waterless Disinfection Gel |
75183-010-01 75183-010-02 75183-010-03 |
Zorin Pharmaceutical Technology Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022 |
09/14/2022 |
|
Unibeleza Industria E Comercio De |
Biotipo Pharma Medical Sanitizing Hand Wipes |
77457-011-01 77457-011-02 77457-011-03 77457-012-01 77457-012-02 77457-013-01 77457-013-02 77457-013-03 |
Biotipo Brazil |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022 |
09/14/2022 |
|
Unibeleza Industria E Comercio De |
Biotipo Pharma Medical Biogel |
77457-000-01 77457-000-02 77457-000-03 77457-000-04 77457-000-05 77457-000-06 77457-000-07 77457-000-08 77457-001-01 77457-001-02 77457-001-03 77457-001-04 77457-001-05 77457-002-01 77457-002-02 77457-002-03 77457-006-01 |
Biotipo Brazil |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022 |
09/14/2022 |
|
Venice Cosmetic |
LK Hand Clean Gel |
74488-012-01 |
Venice Cosmetic |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Venice Cosmetic |
LK New Antiseptic |
74488-003-01 74488-011-01 |
Venice Cosmetic |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Venice Cosmetic |
LK Clean Gel |
74488-001-01 74488-002-01 74488-004-01 74488-005-01 74488-006-01 74488-007-01 74488-008-01 74488-009-01 |
Venice Cosmetic |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. |
08/17/2022 |
|
Skin Farm |
PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil |
73793-0006-1 73793-0007-1 73793-0008-1 |
Sports Med Care, Inc. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2022. |
08/17/2022 |
|
Skin Farm |
Germ War Hand Sanitizer |
73793-0001-1 73793-0002-1 73793-0003-1 73793-0004-1 73793-0005-1 73793-0009-1 73793-0010-1 73793-0011-1 73793-0012-1 |
DJO LLC. |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2022. |
08/17/2022 |
|
Clean Cosmetics, LLC |
TrustRx Medical Grade Hand Sanitizer |
80843-001-01 80843-001-02 80843-001-03 |
Clean Cosmetics, LLC |
Product contains methanol based on information provided by the manufacturer. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a warning letter on 01/30/2023. |
08/03/2022 |
|
Guangdong Theaoson Technology Co. Ltd. (China) |
75% Alcohol Hand Sanitizer Gel |
78792-012-04 78792-012-06 78792-012-07 |
Guangdong Theaoson Technology Co., Ltd. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong Theaoson Technology Co. Ltd. (China) |
Antibacterial Hand Sanitizer with Moisturize Aloe |
78792-012-05 |
Guangdong Theaoson Technology Co., Ltd. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong Theaoson Technology Co. Ltd. (China) |
75% Alcohol Sanitizer |
78792-010-01 78792-012-01 78792-012-02 78792-012-03 |
Guangdong Theaoson Technology Co., Ltd. (China) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
One Drop Care Hand Disinfectant Gel |
75226-004-01 75226-004-02 75226-004-03 75226-004-04 75226-004-05 |
Guangzhou Wantuo Biotechnology Co LTD |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong Theaoson Technology Co. Ltd. (China) |
75% Alcohol Sanitizer Spray |
78792-011-01 78792-011-02 78792-011-03 78792-011-04 |
Guangdong Theaoson Technology Co., Ltd. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
JPR Medical Disinfecting Wipes (75% alcohol) |
54325-004-01 |
Guangdong JunBao Industry Co., Ltd. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
Alcohol Cleaning Wet Wipes |
54325-001-01 54325-002-01 |
Guangdong JunBao Industry Co., Ltd. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
Be Cleaner Be Healthier 75% Alcohol Wipes |
54325-003-01 |
BM Time Co. |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
One Drop Care Alcohol Disinfectant Spray |
75226-001-01 75226-001-02 75226-001-03 75226-001-04 |
Guangzhou Wantuo Biotechnology Co. LTD |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
One Drop Care Alcohol Disinfectant Wet Wipes |
75226-002-01 75226-002-02 75226-002-04 |
Guangzhou Wantuo Biotechnology Co LTD |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
|
Guangdong JunBao Industry Co. Ltd. (China) |
One Drop Care Alcohol Solution |
75226-003-01 75226-003-02 75226-003-03 |
Guangzhou Wantuo Biotechnology Co LTD |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. |
07/20/2022 |
| Hand Sanitizer LLC (Louisiana) |
Hand Sanitizer Say Goodbye to Germs Alcohol Antiseptic 80% Topical Solution |
Not Listed | Hand Cleansing Gel (Louisiana) |
FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. | 4/27/2022 |
| Hand Sanitizer LLC (Louisiana) |
70% Alcohol Cleansing Gel Say Goodbye to Germs | 76701-700-02 76701-700-08 76701-700-17 76701-700-32 |
Hand Cleansing Gel (Louisiana) | Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. | 4/27/2022 |
| Bluebonnet Petrochemical Solutions (USA) | HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution |
75339-751-01 |
EcoWerks | FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022 | 04/06/2022 |
| Aroma Release Technologies, Inc. | Klean Touch Hand Sanitizer |
75076-123-55 75076-234-55 |
Valisa MFG LLC | Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. product voluntarily recalled on 11/30/2021 | 11/24/21 |
| Aroma Release Technologies, Inc. | kleantouch HAND SANITIZER, 8.0 FL OZ |
Not listed |
Valisa MFG LLC | Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021 | 12/15/2021 |
| Aromas Para El Alma SA (Costa Rica) | Erewhon Hand Sanitizer with Eucalyptus Oil | 80751-100-01 80751-200-02 |
Erewhon Market LLC (California) | Product subpotent; product manufactured at a facility that did not respond adequately to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 2/29/2024 | 03/13/2024 |
| Aromas Para El Alma SA (Costa Rica) | Erewhon Antibacterial Spray with Lemon Oil Rosemary Oil Eucalyptus Oil Clove Bud Oil Cinnamon Oil | 80751-300-02 80751-300-07 |
Erewhon Market LLC (California) | Product subpotent; product manufactured at a facility that did not respond adequately to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 02/29/2024. | 03/13/2024 |
|
Dongguan Chunzhen Biological Technology Co., Ltd (China) |
Acvioo Advanced Hand Sanitizer | 71847-1107-3 | Anewish, Inc | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 8/26/2020. | 11/24/21 |
|
HealthMEDS, Inc. Oregon) |
ProClean-Pure Atomizer Mist | 75411-001-02 | HealthMEDS, Inc | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/29/2021. |
11/24/21 |
|
HealthMEDS, Inc. (Oregon) |
ProClean-Pure Atomizer Mist | 75411-001-02 | HealthMEDS, Inc | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/29/2021. | 11/24/21 |
| Ardil Comercial SRL | Alcohol Isopropilico Hand Sanitizer Limar | 77854-030-04 | Ardil Comercial SRL | Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021; product recalled on 7/1/2021; FDA issued a warning letter on 09/22/2021 | 06/16/2021 |
| 4E Global SAPI de CV (Mexico) | Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe | 60599-018-00 60599-018-02 60599-018-04 |
4E Brands North America LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E | 60599-015-00 | 4E Brands North America LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E | 60599-015-01 60599-015-02 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/11/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | KLAR AND DANVER Instant Hand Sanitizer | 33992-8010-1 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | MODESA Instant Hand Sanitizer Moisturizers and Vitamin E | 60599-007-33 | Midwood Brands LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer | 60599-012-04 60599-012-08 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer | 60599-012-00 60599-012-01 60599-012-02 60599-012-03 60599-012-05 60599-012-06 60599-012-07 60599-012-10 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer Aloe | 60599-013-00 60599-013-01 60599-014-00 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Instant Hand Sanitizer Lavender | 60599-016-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Hand Sanitizer | 60599-018-02 60599-018-04 60599-018-06 60599-018-07 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Hand Sanitizer | 60599-017-00 60599-018-01 60599-018-02 60599-018-04 60599-018-06 60599-018-07 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear LEAR Advanced Hand Sanitizer | 60599-017-00 60599-018-01 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear LEAR Advanced Hand Sanitizer | 60599-017-01 60599-018-03 60599-018-05 60599-018-08 60599-019-00 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | The Honeykeeper Hand Sanitizer | 60599-020-00 60599-020-01 |
4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Advanced Hand Sanitizer Clear | 60599-024-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Instant Hand Sanitizer | 60599-025-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Instant Hand Sanitizer Aloe | 60599-026-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Clear Advanced Instant Hand Sanitizer Lavender | 60599-027-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol | 60599-028-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol | 60599-029-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol | 60599-046-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol | 60599-047-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Blumen Antibacterial Fresh Citrus Hand Sanitizer | 60599-501-01 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Blumen Hand Sanitizer Fresh Citrus | 60599-502-01 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | KLAR and DANVER Instant Hand Sanitizer | 60599-801-00 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product | 60599-802-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Assured Instant Hand Sanitizer (Vitamin E and Aloe) | 60599-850-00 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Assured Instant Hand Sanitizer (Aloe and Moisturizers) | 60599-851-00 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Assured Instant Hand Sanitizer Vitamin E and Aloe | 60599-852-00 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Assured Instant Hand Sanitizer Aloe and Moisturizers | 60599-853-00 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Instant Hand Sanitizer Fragrance Free | 60599-854-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | BLUMEN Instant Hand Sanitizer Aloe Vera | 60599-855-00 | 4E Brands North America LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020 | 07/08/2020 |
| 4E Global SAPI de CV (Mexico) | Assured Aloe | 60599-999-10 | Greenbrier International Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers | 07/08/2020 |
| AAA Cosmetica (Mexico) | bio aaa Advance Hand Sanitizer | 76987-402-01 74840-402-01 |
Payless Janitorial Corporation | FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 7/14/2020; FDA issued a warning letter on 2/3/2021 | 07/06/2020 |
| AAA Cosmetica (Mexico) | bio aaa Advance Hand Sanitizer 480 mL bottles | Not listed | AJR Trading LLC | Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 9/3/2020; FDA issued a warning letter on 2/3/2021 | 09/04/2020 |
| AAA Cosmetica (Mexico) | LumiSkin Advance Hand Sanitizer | 76987-120-01 | Soflo Urban Team LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/2021 | 07/06/2020 |
| AAA Cosmetica (Mexico) | LumiSkin Advance Hand Sanitizer | 76987-402-02 | Soflo Urban Team LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/2021 | 07/06/2020 |
| AAA Cosmetica (Mexico) | QualitaMed Hand Sanitizer | 76987-250-01 | QualitaMed Corp. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/2021 | 07/06/2020 |
| Albek de Mexico SA de CV (Mexico) | NEXT Hand Sanitizer | 50066-605-08 | Genomma Lab USA | FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | NuuxSan Instant Antibacterial Hand Sanitizer | 72758-001-08 72758-002-08 |
Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | NuuxSan Instant Hand Sanitizer | 72758-003-00 72758-003-01 72758-005-01 72758-005-02 72758-005-03 |
Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers | 72758-009-23 | Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe | 72758-010-23 | Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera | 72758-011-23 | Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Albek de Mexico SA de CV (Mexico) | Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E | 72758-012-23 | Albek de Mexico SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/2021 | 07/28/2020 |
| Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico) | Argent Defense Group Hand Sanitizer | 77927-100-07 77927-100-11 |
ABN Corporation | FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/2021 | 09/01/2020 |
| Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico) | Dolphin Hands Sanitizer | 77927-100-04 77927-100-08 |
Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico) | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/2021 | 09/01/2020 |
| Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico) | Hand Sanitizer Antiseptic Hand Gel 70-2 | 77927-100-05 77927-100-06 77927-100-09 77927-100-10 |
Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico) | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/2021 | 09/01/2020 |
| Asiaticon SA de CV (Mexico) | V-KLEAN Hand Sanitizer Gel | Not listed | Astrum LLC | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | V-KLEAN Hand Sanitizer Gel | 75192-001-01 75192-002-04 |
Asiaticon | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | V-KLEAN Hand Sanitizer Gel | 75192-002-01 75192-002-02 |
Acadia Mercantil Corp. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | V-KLEAN Hand Sanitizer Gel | 75192-002-03 | Protex Labs | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages) | 75192-003-01 75192-003-02 75192-003-03 |
Protex Labs | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | V-KLEAN | 75192-100-01 | SWCH LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | Medically Minded Hand Sanitizer Gel | 75192-500-01 75192-600-01 |
SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada) | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Asiaticon SA de CV (Mexico) | Protz Real Protection Antibacterial Hand Sanitizer | 75192-600-02 | Safety-Med Products | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020 | 08/06/2020 |
| Bionateo Sp z.o.o. (Poland) |
Altaio Hand Sanitizing Gel | 78571-002-02 | Bionateo Sp z.o.o. (Poland) | FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
| Bionateo Sp z.o.o. (Poland) | Altaio Hand Sanitizing Gel | 78571-002-01 78571-002-03 78571-002-04 78471-002-05 |
Bionateo Sp z.o.o. (Poland) |
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
| Bionateo Sp z.o.o. (Poland) | Altaio Hand Sanitizer Topical Solution | 78581-001-01 78581-001-02 78581-001-03 78581-001-04 78571-001-05 78571-001-06 |
Bionateo Sp z.o.o. (Poland) | Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
|
Bionateo Sp z.o.o.(Poland) |
Altaio Hand Sanitizing Wipes (80% Ethanol) | 78581-003-01 |
Bionateo Sp z.o.o. (Poland) |
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021; FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
|
Bionateo Sp z.o.o. (Poland) |
Altaio Hand Sanitizing Wipes (70% Ethanol) | 78571-004-01 | Bionateo Sp z.o.o. (Poland) | Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021; FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
|
Bionateo Sp z.o.o.(Poland) |
Altaio Hand Sanitizer Spray |
78571-005-01 78571-005-02 78571-005-03 |
Bionateo Sp z.o.o. (Poland) | Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021; FDA issued a warning letter on 11/4/2021 | 05/26/2021 |
| Bon Cosmetics Co., Ltd. (Korea) | Perfect Hand Sanitizer |
74001-0002-1 74001-0004-1 74001-0005-1 74001-0006-1 |
Bon Cosmetics Co., Ltd. (Korea) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 | 06/01/2022 |
| Bon Cosmetics Co., Ltd. (Korea) |
BVG Zero Hand Sanitizer BVG Clean Hand Sanitizer |
74001-0001-1 74001-0003-1 |
Bon Cosmetics Co., Ltd. (Korea) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 | 06/01/2022 |
| Bon Cosmetics Co., Ltd. (Korea) | Naturia Professional Green Hand Sanitizer | 74001-0007-1 | Bon Cosmetics Co., Ltd. (Korea) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 | 06/01/2022 |
| Bon Cosmetics Co., Ltd. (Korea) | Essentials by Urban Secrets Hand Sanitizer |
75585-030-01 75585-050-01 75585-050-02 75585-050-03 75585-070-01 75585-070-02 75585-070-03 75585-070-04 |
Pro’s Choice Beauty Care (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 | 06/01/2022 |
| Bon Cosmetics Co., Ltd. (Korea) | Essentials by Urban Secrets Advanced Hand Sanitizer |
75585-040-01 75585-060-01 |
Pro’s Choice Beauty Care (New York) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 | 06/01/2022 |
| Botanicals Internacional SA de CV (Mexico) | Alcohol Antiseptic 80% topical solution hand sanitizer | 51384-001-01 51384-001-02 |
Pure Haven | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol | 51384-002-01 | Inambtec SA de CV | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | All Clear Hand Sanitizer Fragrance Free | 51384-004-01 | Good Fibers LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | Total Pure Alcohol Based Hand Sanitizer Gel | 51384-003-01 51384-003-02 |
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 | |
| Botanicals Internacional SA de CV (Mexico) | 70% Alcohol Gel Hand Sanitizer | 51384-500-10 51384-500-11 51384-500-23 51384-500-47 51384-500-94 |
USMed Supplies LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | ResQue 1st Instant Hand Sanitizer | 73762-100-10 73762-100-11 73762-100-23 73762-100-47 73762-100-94 |
Quick Aid LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | 70% Alcohol Gel Hand Sanitizer | 78072-400-10 78072-400-11 78072-400-23 78072-400-47 78072-400-94 |
LTD Enterprises Distribution | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Botanicals Internacional SA de CV (Mexico) | 70% Alcohol Gel Hand Sanitizer | 78072-500-10 78072-500-11 78072-500-23 78072-500-47 78072-500-94 |
USMed Supplies LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021 | 08/06/2020 |
| Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi) | Comfort & Mercy Hand Sanitizer | 75179-303-03 | Cathead Distillery | FDA tested product; contains acetaldehyde and acetal contaminants. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. FDA recommended the company recall on 06/01/2022. | 06/01/2022 |
| Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi) | Comfort & Mercy Hand Sanitizer |
75179-313-05 75179-313-16 |
Cathead Distillery | Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. FDA recommended the company recall on 06/01/2022. | 06/01/2022 |
| Broncolin SA de CV (Mexico) | Herbacil Antiseptic Hand Sanitizer 70% Alcohol | 62583-020-08 | INBC Trading LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/2020 | 07/24/2020 |
| Broncolin SA de CV (Mexico) | Herbacil Antiseptic Hand Sanitizer 70% Alcohol | 62583-020-16 62583-020-33 62583-020-42 |
INBC Trading LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/2020 | 07/24/2020 |
| Broncolin SA de CV (Mexico) | Herbacil Antiseptic Hand Sanitizer 70% Alcohol | 74673-001-08 74673-001-16 74673-001-33 74673-001-42 |
INBC Trading LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/2020 | 07/24/2020 |
| C&G Laboratorios SA de CV (Mexico) | Hand Sanitizer Disenfectant Gel | Not Listed | Access USA | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/9/2020 | 10/01/2020 |
| Corporativo Bureli SA de CV (Mexico) | Soho Fresh Hand Sanitizer Gel Antibacterial | 79081-000-03 | SOHO Fresh | FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020 | 09/16/2020 |
| Corporativo Bureli SA de CV (Mexico) | SOHO Fresh Hand Sanitizer Gel Antibacterial | 79081-000-01 79081-000-02 79081-000-04 78533-000-02 78533-000-08 78533-000-16 78533-000-33 |
SOHO Fresh and Essaar Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020 | 09/16/2020 |
| Corporativo Bureli SA de CV (Mexico) | SOHO Fresh Rubbing Alcohol | 78533-001-33 | SOHO Fresh | Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by Essaar Inc. on 1/4/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020 | 01/11/2021 |
| David Cosmetic Co, Ltd. (Korea) |
CALA Advanced Hand Sanitizer with Aloe Vera Extract | 58241-0009-1 | CALA Products (California) | FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2022; FDA issued a warning letter on 05/02/2022 | 01/12/2022 |
| DDI Multinacional SA de CV (Mexico) | Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced | 74949-002-20 74949-002-25 74949-002-49 74949-002-60 |
Earths Amenities | FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020; FDA issued a warning letter on 06/27/2022 | 07/08/2020 |
| DDI Multinacional SA de CV (Mexico) | Hand Sanitizer Agavespa Skincare | 77415-000-00 | Vidanos Easy Cleaning Rentals | FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020; FDA issued a warning letter on 06/27/2022 | 07/08/2020 |
| DDI Multinacional SA de CV (Mexico) | Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare | 77056-000-01 | Vidanos Easy Cleaning Rentals | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020; FDA issued a warning letter on 06/27/2022 | 07/08/2020 |
| DEPQ Internacional S de RL de CV (Mexico) | dgreen Advanced Sanitizer Alcohol Free | 74155-211-04 74155-211-07 74155-211-08 74155-211-19 74155-211-20 74155-211-38 |
Biokaab Inc. | FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/2021 | 08/03/2020 |
| DEPQ Internacional S de RL de CV (Mexico) | dgreen Advanced Hand Sanitizer Antibacterial Gel | 74155-201-03 74155-201-19 74155-201-20 74155-201-38 |
Biokaab Inc. | Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/2021 | 08/03/2020 |
| DEPQ Internacional S de RL de CV (Mexico) | Hand Sanitizer | 74155-111-07 74155-111-08 74155-111-19 74155-111-20 74155-111-38 |
Biokaab Inc. | Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/2021 | 08/03/2020 |
| DEPQ Internacional S de RL de CV (Mexico) | Hand Sanitizer Gel | 74155-101-07 74155-101-08 74155-101-19 74155-101-20 74155-101-38 |
Biokaab Inc. | Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/2021 | 08/03/2020 |
| DEPQ Internacional S de RL de CV (Mexico) | Clean Humans Hand Sanitizer | Not listed | Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/2021 | 08/03/2020 | |
| Dibar Nutricional S De RL de CV (Mexico) | Dibar Labs Hand Sanitizer | 73009-001-08 | S.E.N.D. LLC | FDA tested product; contains methanol; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Dibar Labs Hand Sanitizer | 73009-001-16 73009-003-04 73009-003-32 |
S.E.N.D. LLC | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | ProtectoRx Hand Sanitizer Extra Strength | 73009-002-01 73009-002-02 75408-002-01 75408-002-02 |
PR Trading LLC | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Eztizer Hand Sanitizer | 73009-005-01 73009-005-02 73009-005-03 73009-005-04 73009-005-05 73009-005-06 |
Dibar Labs | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Advance Hand Sanitizer | 73009-010-00 79284-005-00 |
Lifetime Health Services | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Basic Care Gel Hand Sanitizer | 73009-015-01 73009-015-02 79695-015-01 79695-015-02 |
Nora Foods Inc. | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Genesis Today Advanced Hand Sanitizer | 73009-016-01 62400-0016-1 |
West Town Brands | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Wellnicity Hand Sanitizer | 73009-017-01 62400-0017-1 |
Wellnicity | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Dibar Nutricional S De RL de CV (Mexico) | Bklen Hands Sanitizer | 73009-018-01 73009-018-02 73009-018-03 73009-018-04 73009-018-05 81081-000-01 81081-000-02 81081-000-03 81081-000-04 81081-000-05 |
Garflo Foods | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/2021 | 04/29/2021 |
| Distribuidora Lagunera del Norte SA de CV (Mexico) | Weper Clean Solutions | 76527-001-03 | Ekko’s Venture LLC | FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/2021 | 01/28/2021 |
| Distribuidora Lagunera del Norte SA de CV (Mexico) | Weper Clean Solutions | 76527-001-01 76527-001-02 76527-001-04 76527-001-05 76527-001-06 76527-001-07 |
Ekko’s Venture LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/2021 | 01/28/2021 |
| Distribuidora Lagunera del Norte SA de CV (Mexico) | CyroLab Q&T Antibacterial Gel | 78907-001-01 78907-001-02 78907-001-03 78907-001-04 78907-001-05 |
Distribuidora Lagunera del Norte SA de CV | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/2021 | 01/28/2021 |
| Distribuidora Lagunera del Norte SA de CV (Mexico) | Kleengel Hand Sanitizer | 76527-002-01 76527-002-02 76527-002-03 76527-002-04 76527-002-05 76527-002-06 76527-002-07 76527-002-02 |
Comdata Laguna S de RL de CV | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/2021 | 01/28/2021 |
| Distribuidora Lagunera del Norte SA de CV (Mexico) | Kilvir Forte Virus Killer | 76527-003-01 76527-003-02 76527-003-03 76527-003-04 76527-003-05 76527-003-06 76527-003-07 76527-003-08 |
Comdata Laguna S de RL de CV | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/2021 | 01/28/2021 |
| DMM Vission SA de CV (Mexico) | SYP Health Hand Sanitizer Alcohol Gel | 75799-000-03 | FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a Warning Letter on 06/03/2021 | 08/21/2020 | |
| DMM Vission SA de CV (Mexico) | Cleaner by Crystalware Hand Sanitizer Alcohol Gel | 74840-402-05 | CrystalWare | FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a Warning Letter on 06/03/2021 | 08/21/2020 |
| DMM Vission SA de CV (Mexico) | Cleaner by Crystalware Hand Sanitizer Alcohol Gel | 75799-000-02 75799-000-04 |
CrystalWare | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled on 9/8/2020; FDA issued a Warning Letter on 06/03/2021 | 08/21/2020 |
| DMM Vission SA de CV (Mexico) | SYP Health Hand Sanitizer Alcohol Gel | 75799-000-01 | Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a Warning Letter on 06/03/2021 | 08/21/2020 | |
| Eskbiochem SA de CV (Mexico) | CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol | 74589-009-01 | ESPMEX LLC | FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | Lavar 70 Gel Hand Sanitizer | 74589-006-01 | Blue Ridge Southern Supply LLC | FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | All-Clean Hand Sanitizer | 74589-002-01 | All Clean Natural LTD | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by ITECH 361 on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | Esk Biochem Hand Sanitizer | 74589-007-01 | EskBiochem | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | The Good Gel Antibacterial Gel Hand Sanitizer | 74589-010-10 | EskBiochem SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol | 74589-005-03 | ESPMEX LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol | 74589-003-01 | ESPMEX LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Eskbiochem SA de CV (Mexico) | Saniderm Advanced Hand Sanitizer | 74589-001-01 | Polarized LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by Saniderm Products on 6/26/2020 and UVT Inc. on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020 | 07/02/2020 |
| Estrategia Hospitalaria SA de CV (Mexico) | OZO Hand Sanitizer, Luxury Formula | Not listed | Ancorp Capital Group USA | FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020 | 08/06/2020 |
| Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico) | Pristine Hand Sanitizer Gel | 76938-001-01 | Universal Distributors LLC | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/2021 | 11/20/2020 |
| Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico) | Pristine Hand Sanitizer Gel | 76938-001-02 76938-001-03 |
Universal Distributors LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/2021 | 11/20/2020 |
| Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico) | Zapien Productos Hand Sanitizer Gel | 76938-100-02 | Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico) | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/2021 | 11/20/2020 |
| Genesis Partnership Company SA (Guatemala) | Panagel Hand Sanitizer | 78384-001-01 72384-001-02 78384-001-03 78384-001-04 |
Central-Med Distribution Inc. | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | Panagel Hand Sanitizer | 74625-002-01 74625-002-04 74625-002-05 74625-003-01 74625-003-04 74625-003-05 |
Killz Germz LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | Panagel Hand Sanitizer | 76988-001-01 76988-001-03 |
DJR Trading | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | SensiMedical Hand Sanitizer Gel | 78718-763-01 78718-763-02 78718-763-03 78718-763-04 78718-763-05 78718-763-06 |
Sensimedical LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | Genesis Hand Sanitizer Gel | 74484-001-01 74484-001-02 74484-001-03 74484-001-04 74484-002-01 74484-002-02 74484-002-03 74484-002-04 74484-002-05 74484-002-06 |
Genesis Partnership Company SA (Guatemala) | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | Medtek Supplies Hand Sanitizer | 78901-001-01 | Wide Evolution Systems | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020 | 08/28/2020 |
| Genesis Partnership Company SA (Guatemala) | Bathletix HAND SANITIZER | 74484-002-01; 74484-002-02 | BH Deals & Closeout, Inc. | Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021. | 09/08/2021 |
| Grupo Asimex de Mexico SA de CV (Mexico) | Florance Morris Body Care Antispetic Hand Sanitizer | 76612-170-06 76612-170-10 76612-170-11 76612-170-12 76612-170-25 76612-170-37 76612-170-50 76612-180-10 76612-180-12 76612-180-25 76612-180-37 76612-180-50 |
Asimex International LLC | FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/2020 | 08/13/2020 |
| Grupo Asimex de Mexico Sa de CV (Mexico) | Florance Morris Body Care Antispetic Hand Sanitizer | 77409-170-06 77409-170-10 77409-170-11 77409-170-12 77409-170-25 77409-170-37 77409-170-50 77409-180-10 77409-180-12 77409-180-25 77409-180-37 77409-180-50 |
Asimex International LLC | FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/2020 | 08/13/2020 |
| Grupo Asimex de Mexico Sa de CV (Mexico) | Florance Morris Body Care Antispetic Hand Sanitizer | 79109-170-06 79109-170-10 79109-170-11 79109-170-12 79109-170-22 79109-170-25 79109-170-37 79109-170-50 |
Roldan Industries | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/2020 | 08/13/2020 |
| Grupo Insoma S.A.P.I de CV (Mexico) | Hand sanitizer Gel Unscented 70% Alcohol | 75744-0200-3 75744-0200-4 75744-0201-5 75744-0202-1 75744-0250-1 75744-0250-2 75744-0500-1 75744-1000-1 75744-1000-3 75744-1001-1 |
Grupo Insoma S.A.P.I de CV | FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 10/23/2020 | 07/02/2020 |
| Grupo Insoma S.A.P.I de CV (Mexico) | Hand sanitizer Gel Unscented 70% Alcohol | Not listed | CIRG Waste & Recycling Solutions US LLC | FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 10/23/2020 | 08/06/2020 |
| Grupo Plast Y Kosas SA de CV (Mexico) | M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer | 75432-001-02 | Medek LLC | FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled by Medek LLC on 9/9/2020; FDA issued a warning letter on 1/25/2021 | 08/11/2020 |
| Grupo Plast Y Kosas Sa De CV (Mexico) | Hand Sanitizer Alcohol Antiseptic topical solution 80% | 77797-001-01 75432-001-01 |
Medek LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/2021 | 08/11/2020 |
| Grupo Plast Y Kosas SA de CV (Mexico) | Jalisco Paper Inc. Restaurant Supplies Hand Sanitizer | 77797-001-02 75432-001-03 |
Medek LLC | FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/2021 | 08/11/2020 |
| Grupo Plast Y Kosas SA de CV (Mexico) | O.K. Pharmacy Hand Sanitizer | 77797-001-03 75432-001-04 |
Medek LLC | FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/2021 | 08/11/2020 |
| Grupo Yacana Mexico SAS de CV (Mexico) | Yacana Alcohol Antiseptic 70% Topical Solution | 76592-002-01 76592-002-02 76592-002-03 76592-002-04 76592-002-05 76592-002-06 76592-002-07 |
Greensys of North America LLC | FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021 | 08/13/2020 |
| Grupo Yacana Mexico SAS de CV (Mexico) | Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution | 76592-001-01 76592-001-02 76592-001-03 76592-001-04 |
Greensys of North America LLC | FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021 | 08/13/2020 |
| Grupo Yacana Mexico SAS de CV (Mexico) | Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel | 76592-003-01 76592-003-02 76592-004-01 76592-004-02 |
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021 | 08/13/2020 | |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | IMC Wash-Free Hand Sanitizer | Not listed | IMC | FDA tested product; contains methanol; product voluntarily recalled by Shane Erickson on 12/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the manufacturer recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | Yuame Wash-Free Hand Sanitizer Gel | 75132-001-01 75132-001-02 75132-001-03 75132-001-04 75132-001-05 75132-001-06 75132-001-07 75132-001-08 75132-001-09 75132-001-10 75132-001-11 75132-001-12 75132-001-13 75132-001-14 75132-001-15 75132-001-16 75132-001-17 |
Guangdong Kemei Pharmaceutical Technology Co. Ltd | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | Yuame 75% Alcohol Disinfectant | 75132-002-01 75132-002-02 75132-002-03 75132-002-04 75132-002-05 75132-002-06 75132-002-07 75132-002-08 75132-002-09 75132-002-10 |
Guangdong Kemei Pharmaceutical Technology Co. Ltd | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | Yuame Wash-Free Hand Sanitizer Gel | 75132-011-01 75132-011-02 75132-011-03 |
Guangdong Kemei Pharmaceutical Technology Co. Ltd | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | KLEAN KARE Hand Sanitizer Industrial and Hospital Grade | 77205-001-01 77205-001-02 |
AMG LLC | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
| Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China) | Essentials, M.D. Hand Sanitizer Industrial and Hospital Grade | 77205-002-01 77205-002-02 |
AMG LLC | Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021 | 12/15/2020 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
Vertra Hand Sanitizer Topical Solution
|
52807-103-01 52807-103-02 52807-103-03 52807-103-04 52807-103-05 52807-103-06 52807-103-07 52807-103-08 52807-103-09 52807-103-10 |
EAI-JR286 Inc. (California)
|
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/05/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China)
|
“ssential” Hand Sanitizer |
52807-002-01 52807-003-01 52807-004-01 52807-005-01 52807-006-01 52807-007-01 52807-008-01 52807-009-01 52807-010-01 52807-011-01 52807-012-01 52807-013-01 52807-014-01 |
LLF Phoenix LLC (Nevada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
“ssential” Aloe Vera Gel Hand Sanitizer |
52807-015-01 52807-016-01 52807-017-01 52807-018-01 52807-019-01 52807-020-01 |
LLF Phoenix LLC (Nevada) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
“ts” By Tara - Clean Up Hand Sanitizer |
52807-021-01 52807-021-02 52807-021-03 |
Guangdong Longtai Industry Co., Ltd. (China)
|
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
Eco-Planet Pura Advanced Hand Sanitizer
|
52807-001-01
|
Guangdong Longtai Industry Co., Ltd. (China)
|
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
Spa Da Health PROmmunity Hand Sanitizer |
52807-022-01 52807-022-02 |
Accel Inc. (Ohio) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China) |
Healing Solutions Premium Hand Sanitizer |
52807-101-01 52807-101-02 52807-101-03 52807-101-04 52807-101-05 52807-101-06 52807-101-07 52807-101-08 52807-101-09 52807-101-10 52807-101-11 52807-101-12 52807-101-13 52807-101-14 52807-101-15 52807-101-16 52807-101-17 52807-101-18 52807-101-19 52807-101-20 52807-101-21 52807-101-22 52807-101-23 52807-101-24 52807-101-25 52807-101-26 52807-101-27 52807-101-28 52807-101-29 52807-101-30 52807-101-31 52807-101-32 52807-101-33 52807-101-34 52807-101-35 52807-101-36 52807-101-37 52807-101-38 52807-101-39 52807-101-40 52807-101-41 52807-101-42 52807-101-43 52807-101-44 52807-101-45 |
Healing Solutions LLC (Arizona) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangdong Longtai Industry Co., Ltd. (China)
|
Roots Aromatherapy Hand Sanitizer |
52807-102-01 52807-102-02 52807-102-03 52807-102-04 52807-102-05 52807-102-06 52807-102-07 52807-102-08 52807-102-09 52807-102-10 52807-102-11 52807-102-12 52807-102-13 52807-102-14 52807-102-15 52807-102-16 52807-102-17 52807-102-18 52807-102-19 52807-102-20 52807-102-21 52807-102-22 52807-102-23 52807-102-24 52807-102-25 52807-102-26 52807-102-27 52807-102-28 52807-102-29 52807-102-30 52807-102-31 52807-102-32 52807-102-33 52807-102-34 52807-102-35 52807-102-36 52807-102-37 52807-102-38 52807-102-39 52807-102-40 52807-102-41 52807-102-42 52807-102-43 52807-102-44 52807-102-45 52807-102-46 52807-102-47 52807-102-48 52807-102-49 52807-102-50 52807-102-51 52807-102-52 52807-102-53 52807-102-54 52807-102-55
|
Hotel Emporium Inc
(California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
|
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China) |
Cisimonn No-washing Disinfection Gel |
78278-102-01 78278-102-02 78278-102-03 78278-102-04 78278-102-11 78278-102-12 78278-102-13 78278-102-14 78278-102-15 |
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
| Guangzhou Minghui Cosmetics Co. Ltd. (China) | Qi Yu Hand Sanitizer | 74447-012-01 | Guangzhou Minghui Cosmetics Co. Ltd. | FDA tested product; ethyl alcohol level was subpotent; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021. | 04/12/2021 |
|
Guangzhou Minghui Cosmetics Co. Ltd. (China) |
Qi Yu Hand Sanitizer |
74447-001-01 74447-002-01 74447-003-01 74447-004-01 74447-005-01 74447-006-01 74447-007-01 74447-008-01 74447-009-01 74447-010-01 74447-011-01 74447-012-02 74447-012-03 74447-012-04 74447-012-05 74447-012-06 74447-012-07 74447-012-08 74447-012-09 74447-012-10 |
Guangzhou Minghui Cosmetics Co. Ltd. |
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021. |
04/12/2021 |
|
Guangzhou Minghui Cosmetics Co. Ltd. (China) |
Qi Yu Medical Alcohol Disinfectant |
74447-101-01 74447-101-02 74447-101-03 74447-101-04 74447-101-05 74447-101-06 74447-101-07 74447-101-08 74447-101-09 74447-101-10 74447-101-11 74447-101-12 74447-101-13 74447-101-14 74447-101-15 74447-101-16 74447-101-17 |
Guangzhou Minghui Cosmetics Co. Ltd. |
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021. |
04/12/2021 |
|
Guangzhou Minghui Cosmetics Co. Ltd. (China) |
Waxman Kleen Freak Hand Sanitizer |
74447-106-01 |
Waxman Industries |
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021. |
04/12/2021 |
| Guangzhou Youxing Cosmetics Co. Ltd.(China) | V&W Advance Hand Sanitizer Refreshing Gel | 75239-005-09 | Val USA Manufacturer Inc. | FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021 | 10/01/2020 |
| Guangzhou Youxing Cosmetics Co. Ltd. (China) | V&W Advance Hand Sanitizer Refreshing Gel | 75239-005-01 75239-005-02 75239-005-03 75239-005-04 75239-005-05 75239-005-06 75239-005-07 75239-005-08 75239-005-10 75239-005-11 75239-005-12 75239-005-13 75239-005-14 75239-005-15 75239-005-16 75239-005-17 |
Val USA Manufacturer Inc. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021 | 10/01/2020 |
| Guangzhou Youxing Cosmetics Co. Ltd. (China) | V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.] | 75239-006-01 75239-006-02 75239-006-03 75239-006-04 75239-006-05 75239-006-06 75239-006-07 75239-006-08 75239-006-09 75239-006-10 75239-006-11 75239-006-12 75239-006-13 75239-006-14 75239-006-15 75239-006-16 75239-006-17 75239-006-18 75239-006-19 75239-006-20 |
Val USA Manufacturer Inc. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021. | 10/01/2020 |
| Guangzhou Youxing Cosmetics Co. Ltd. (China) | V&W Premium Disinfecting Wipes | 75239-007-01 | Val USA Manufacturer Inc. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021. | 10/01/2020 |
| Guangzhou Youxing Cosmetics Co. Ltd. (China) | V&W Advance Hand Sanitizer Refreshing Gel | 76687-005-01 76687-005-02 76687-005-03 76687-005-04 76687-005-05 76687-005-06 76687-005-07 76687-005-08 76687-005-09 76687-005-10 76687-005-11 76687-005-12 76687-005-13 76687-005-14 76687-005-15 76687-005-16 76687-005-17 76687-005-18 76687-005-19 76687-005-20 |
Val USA Manufacturer Inc. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021. | 10/01/2020 |
| Guangzhou Youxing Cosmetics Co. Ltd. (China) | V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.] | 76687-006-01 76687-006-02 76687-006-03 76687-006-04 76687-006-05 76687-006-06 76687-006-07 76687-006-08 76687-006-09 76687-006-10 76687-006-11 76687-006-12 76687-006-13 76687-006-14 76687-006-15 76687-006-16 76687-006-17 76687-006-18 76687-006-19 76687-006-20 |
Val USA Manufacturer Inc. | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021. | 10/01/2020 |
| Guangzhou Minghui Cosmetics Co. Ltd. (China) | Qi Yu Hand Sanitizer |
74447-010-01 | Guangzhou Minghui Cosmetics Co. Ltd. |
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021 |
7/21/2021 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Cloudz instant hand sanitizer |
74935-020-00 74935-020-01 79860-020-00 79860-020-01 |
Solaray, LLC (Oklahoma) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Artnaturals Hand Sanitizer Infused with Jojoba Oil |
74935-016-00 74935-018-00 78706-016-00 78706-018-00 |
Artnaturals (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Orchard De Flore Instant Hand Sanitizer |
74935-015-00 74935-015-01 78733-015-00 78733-015-01 |
Sonora Corp. (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Premium Nature Hand Sanitizer |
74935-010-04 74935-010-08
|
Premium Nature (New Jersey) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Artnaturals Hand Sanitizer Scent Free |
74642-002-00 74935-002-00 |
Artnaturals (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Germ Free Anti-Bacterial Instant Hand Sanitizer |
74935-003-00 76782-003-00 |
Blue Mineral Corporation (New Jersey) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Purago Advanced Hand Sanitizer |
74935-004-00 74935-012-00 76812-004-00 76812-009-00 |
Puraall, LLC (Georgia) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
CB Advanced Hand Sanitizer |
74935-005-00 74935-014-00 76813-005-00 76813-014-00 |
CB Distributors, Inc. (Wisconsin) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Orchard De Flore Instant Hand Sanitizer |
74935-006-00 74935-006-01 74935-006-02 74935-006-03 |
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China)
|
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
True Wash Instant Hand Sanitizer |
74935-007-00 74935-007-01 74935-007-02 74935-007-03 75478-007-00 75478-007-01 75478-007-02 75478-007-03 |
Supply Chain Sources, LLC (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Eluo Advanced Hand Sanitizer with Aloe |
74935-008-00 76869-008-00 |
Titan TD, Inc (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Apollo Instant Hand Sanitizer Anti Bacterial |
74935-009-00 |
Apollo Distributors (Texas) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
SureSafe Handsanitizer Gel with Aloe |
74935-011-00 74935-011-01 78111-010-00 78111-010-01 |
JAB Holdings, LLC (Hawaii) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Health & Wellness Essentials Hand Sanitizer Wash-Free |
74935-017-00 |
Health & Wellness Essentials, Inc (California) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
New Sanicol Advanced Antibacterial Hand Sanitizer |
74935-019-00 79254-019-00 |
AM Beauty Distributors (New York) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
Uncle Jed’s Cold Remedy Hand Sanitizer |
74935-021-01 81172-000-01 |
Earth Sense Energy Systems, Inc (Wisconsin) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
|
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd (China) |
EA Instant Hand Sanitizer |
74935-013-00 74935-013-01 74935-013-02 74935-013-03 74935-013-04 78233-013-00 78233-013-01 78233-013-02 78233-013-03 78233-013-04 |
National Travel Products, Inc (New Jersey) |
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. |
06/08/2022 |
| Harmonic Nature S de RL de MI (Mexico) | Alcohol Antiseptic 75% Topical Solution Hand Sanitizer | 76949-234-01 76949-234-02 76949-235-01 76949-235-02 |
FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020; FDA issued a warning letter on 11/16/2020 | 08/12/2020 | |
| Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico) | HF&N Lab Medi Care Alcohol Antiseptic Topical Solution | 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02 | Healthy Food and Nutrition Lab | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 09/29/2021 | 07/30/2020 |
| Hou Fu Biotech (Jiansu) Co. Ltd. (China) | PANROSA Instant Hand Sanitizer Aloe Vera | 76766-001-01 | Panrosa Enterprise Inc. | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020; FDA issued a warning letter on 4/12/2021 | 11/13/2020 |
| Hou Fu Biotech (Jiansu) Co. Ltd. (China) | PANROSA Instant Hand Sanitizer Aloe Vera | 50302-013-10 50302-013-60 50302-020-50 76766-001-02 76766-001-03 |
Panrosa Enterprise Inc | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020; FDA issued a warning letter on 4/12/2021 | 11/13/2020 |
| Hou Fu Biotech (Jiansu) Co. Ltd. (China) | PANROSA Instant Hand Sanitizer | 50302-003-00 50302-003-11 50302-003-60 50302-021-50 76766-000-01 76766-000-02 76766-000-03 |
Panrosa Enterprise Inc | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020; FDA issued a warning letter on 4/12/2021 | 11/13/2020 |
| Hou Fu Biotech (Jiansu) Co. Ltd. (China) | EPH Labs Hand Sanitizer | 76766-002-01 76766-002-02 76766-002-03 76766-002-04 |
EPH Labs | Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020; FDA issued a warning letter on 4/12/2021 | 11/13/2020 |
| Ignacio Reyes Gonzalez (Mexico) | Medically Minded Hand Sanitizer Gel Antimicrobial Formula | 77196-003-01 | SBL Brands LLC dba Global Sanitizers LLC (Nevada) | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 1/25/2021 | 08/13/2020 |
| Ignacio Reyes Gonzalez (Mexico) | Alcohol Antiseptic 70% Solution or 80% Solution | 77196-001-02 77196-001-05 77196-001-06 77196-001-07 77196-001-08 77196-002-01 77196-002-02 77196-002-03 77196-002-04 77196-002-05 77196-002-06 77196-002-07 77196-002-08 77196-002-09 77196-002-10 |
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 1/25/2021 | 08/13/2020 | |
| Incredible Products SA de CV (Mexico) | GelBac T Hand Sanitizer | 71761-000-00 | Pacific Coast Global Inc. and Tritanium Labs LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily recalled on 8/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 05/27/2021 | 07/30/2020 |
| Incredible Products SA de CV (Mexico) | Hand Sanitizer | 71761-000-01 71761-000-05 71761-000-10 71761-000-20 71761-000-22 71761-000-37 71761-000-99 |
Pacific Coast Global Inc. and Tritanium Labs LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 05/27/2021 | 07/30/2020 |
| Incredible Products SA de CV (Mexico) | TriCleanz (labeled with “Made in Mexico”) | 71761-001-00 | Tritanium Labs LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 05/27/2021 | 07/30/2020 |
| Incredible Products SA de CV (Mexico) | TriCleanz Tritanium Labs Hand Sanitizer (labeled with “Made in Mexico”) | 77757-111-01 | Tritanium Labs LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 05/27/2021 | 07/30/2020 |
| Industrias Cklass S de RL de CV (Mexico) | Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents | 76528-420-10 | Industrias Cklass S de RL de CV | FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 9/14/2020; FDA issued a warning letter on 06/22/2022 | 09/08/2020 |
| Industrias Cklass S de RL de CV (Mexico) | Industrias Cklass Foaming Hand Sanitizer with Aloe | 76528-420-01 76528-420-02 76528-420-03 76528-420-04 |
Wizard Creations Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 9/14/2020; FDA issued a warning letter on 06/22/2022 | 09/08/2020 |
| Inovaker Lab SA de CV (Mexico) | Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution | 77271-002-01 | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020; FDA issued a warning letter on 2/25/2021 | 09/24/2020 | |
| Inovaker Lab SA de CV (Mexico) | El Bueno Hand Sanitizer | 75719-002-02 | Fiesta Union S de RL de CV | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020; FDA issued a warning letter on 2/25/2021 | 09/24/2020 |
| Inovaker Lab SA de CV (Mexico) | Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75% | 77271-001-01 77271-001-02 77271-001-03 77271-001-04 77271-001-05 77271-001-06 77271-001-07 77271-002-02 77271-002-03 77271-002-04 77271-002-05 77271-002-06 |
Inovaker Lab SA de CV | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020; FDA issued a warning letter on 2/25/2021 | 09/24/2020 |
| Inovaker Lab SA de CV (Mexico) | EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer | 77858-0750-1 77858-0751-1 77858-0752-1 77858-0755-1 77858-0755-2 |
Sayida Group | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020; FDA issued a warning letter on 2/25/2021 | 09/24/2020 |
| Inovaker Lab SA de CV (Mexico) | Inovaker Hand Sanitizer | 78106-002-01 78106-002-02 78106-002-03 78106-002-06 78106-002-07 |
UH Group LLC | Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020; FDA issued a warning letter on 2/25/2021 | 09/24/2020 |
| Ismar Soluciones Dinámicas S de RL de CV (Mexico) | OZO Hand Sanitizer | Not listed | Ancorp Capital Group USA | Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020 | 08/06/2020 |
| Ismar Soluciones Dinámicas S de RL de CV (Mexico) | OZO Ozone Hand sanitizer Gel | 77210-0012-1 77210-0012-2 77210-0012-3 77210-0012-4 |
JS Global Sourcing | Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020 | 08/13/2020 |
| Ismar Soluciones Dinámicas S de RL de CV (Mexico) | Goldsquare Hand Sanitizer | 77210-0009-1 77210-0013-1 |
Exportadora In & Out de RL de CV | Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020 | 08/13/2020 |
| Ismar Soluciones Dinámicas S de RL de CV (Mexico) | Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel | 77210-0010-1 | Exportadora In & Out de RL de CV | Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020 | 08/13/2020 |
| JG Atlas Comercios SA de CV (Mexico) | Sayab Antisepctic Hand Sanitizer 100 | 75292-001-00 | JG Atlas Comercios | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/7/2020; FDA issued a warning letter on 11/6/2020 | 07/30/2020 |
| Jose Miguel Gutierrez Salas (Mexico) | MVP Sanitizing Services Spray Hand Sanitizer | 76947-198-20 76947-198-21 76947-199-21 |
SNS Distribution LLC | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/1/2020; FDA issued a warning letter on 07/21/2022. | 08/19/2020 |
| Laboratorios Jaloma SA de CV (Mexico) | Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E | 65055-600-00 65055-600-01 65055-600-02 |
Laboratorios Jaloma SA de CV | FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/3/2020; FDA issued a warning letter on 1/25/2021 | 07/24/2020 |
| Leiper’s Fork Distillery (Tennessee) | Leiper’s Fork Distillery Bulk Disinfectant per 5 gallon and Leiper’s Fork Distillery 16 oz bottle | Not listed | Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020 | 07/24/2020 | |
| Limpo Quimicos SA de CV (Mexico) | Andy’s Best | 73755-120-01 73755-120-02 73755-120-04 |
Brand Name Distributors | FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 09/30/2021 | 07/08/2020 |
| Limpo Quimicos SA de CV (Mexico) | Andy’s | 73755-110-01 73755-130-02 |
Brand Name Distributors | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 09/30/2021 | 07/08/2020 |
| Limpo Quimicos SA de CV (Mexico) | NeoNatural | 73755-200-01 73755-200-02 |
Brand Name Distributors | FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 09/30/2021 | 07/08/2020 |
| Limpo Quimicos SA de CV (Mexico) | Plus Advanced | 73755-300-01 | Brand Name Distributors | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 09/30/2021 | 07/08/2020 |
| Liqesa Exportacion or Liq-E-SA de CV (Mexico) | Optimus Instant Hand Sanitizer | 75416-001-04 | Liq-E SA de CV | FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020; FDA issued a warning letter on 11/19/2020 | 07/21/2020 |
| Liqesa Exportacion or Liq-E-SA de CV (Mexico) | Optimus Lubricants Instant Hand Sanitizer | 75416-005-01 | Liq-E SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 11/19/2020 | 07/08/2020 |
| Liqesa Exportacion or Liq-E-SA de CV (Mexico) | Optimus Instant Hand Sanitizer | 75416-002-01 75416-004-01 75416-378-04 |
Liq-E SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020; FDA issued a warning letter on 11/19/2020 | 07/21/2020 |
| Maquiladora Miniara SA de CV (Mexico) | Shine and Clean Hand Sanitizer | 76753-001-01 76753-001-02 76753-001-03 |
Maquiladora Miniara SA de CV | FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily recalled on 7/9/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020. FDA issued a warning letter on 12/15/2021 | 07/10/2020 |
| Maquiladora Miniara SA de CV (Mexico) | Selecto Hand Sanitizer | 76753-002-01 | Bodega Latina Corp. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020. FDA issued a warning letter on 12/15/2021 | 07/10/2020 |
| Mirfeel Korea Co., Ltd. (Korea) | The Crème Shop Moisturizing Hand Sanitizer, Peppermint Scented | 75010-130-01 | The Crème Shop (California) | FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 02/23/2022 |
| Mirfeel Korea Co., Ltd. (Korea) |
Moisturizing Hand Sanitizer – Mixed Berries Scented Green Tea Scented 500mL Hello Kitty Watermelon Scent Hello Kitty Strawberry Scent Eucalyptus Scented Green Tea Scented 60mL Green Tea Scented Towlettes Hello Kitty Candy Apple Scent Gudetama Peach Scent |
75010-020-01 |
The Crème Shop (California) | Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 04/13/2022 |
| Mirfeel Korea Co., Ltd. (Korea) |
AOMI Hand Sanitizer Gel and Spray |
75010-010-01 |
Mirfeel Korea Co., Ltd. (Korea) | Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 04/13/2022 |
| Mirfeel Korea Co., Ltd. (Korea) |
CoSo Health Hand Sanitizer |
75010-100-01 |
CoSo Health (Colorado) | Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 04/13/2022 |
| Mirfeel Korea Co., Ltd. (Korea) |
TerraPure Hand Sanitizer |
75010-150-01 |
TerraPure Sanitizer Inc. (Canada) | Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 04/13/2022 |
| Mirfeel Korea Co., Ltd. (Korea) |
Instant Hand Sanitizer with natural extracts Instant Hand Sanitizer Wipes |
74443-010-15 |
The Australian Wellness Co (Australia) | Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a warning letter on 06/22/2022 | 04/13/2022 |
| MXL Comercial SA de CV (Mexico) | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol | 77106-002-01 | Resource Recovery and Trading LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020; FDA issued a warning letter on 11/10/2020 | 07/15/2020 |
| MXL Comercial SA de CV (Mexico) | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub | 77106-001-01 77106-001-02 77106-001-03 77106-001-04 77106-001-05 77106-001-06 77106-001-07 77106-001-08 |
Resource Recovery and Trading LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020; FDA issued a warning letter on 11/10/2020 | 07/15/2020 |
| MYM Hidrominerales SA de CV (Mexico) | Protz Real Protection Antibacterial Hand Sanitizer | 77872-600-40 | Safety-Med Products Inc. | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/27/2020; FDA issued a warning letter on 4/9/2021 | 08/17/2020 |
| Mystic International SA de CV (Mexico) | Mystic Shield Protection hand sanitizer | 75477-435-02 75477-435-10 75477-435-12 75477-435-25 75477-435-50 75477-534-10 |
Transliquid Technologies LLC | Company tested product; contains methanol; product voluntarily recalled by Transliquid Technologies LLC on 7/2/2020 | 07/02/2020 |
| Nanomateriales SA de CV (Mexico) | Zanilast + Gel | 69912-006-01 | Nanomateriales SA de CV | FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily recalled on 8/26/2020; added manufacturer to import alert (66-78) to help stop their products from entering the U.S. on 8/31/2020; added to import alert (66-40) on 1/12/2021; FDA issued a warning letter on 09/15/2021 | 08/17/2020 |
| Nanomateriales SA de CV (Mexico) | Zanilast + Gel | 69912-008-01 69912-008-02 69912-009-03 69912-009-04 69912-009-05 69912-009-06 |
Fujimura Trading SA de CV | Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily recalled on 8/26/2020; added manufacturer to import alert (66-78) to help stop their products from entering the U.S. on 8/31/2020; added to import alert (66-40) on 1/12/2021; FDA issued a warning letter on 09/15/2021 | 08/17/2020 |
| Neoingenium Labs SA de CV Hand sanitizer (Mexico) | CleansePure 70% Alcohol | 77031-505-01 | Distribu LLC | FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/18/2020; FDA issued a warning letter on 3/31/21 | 09/11/2020 |
| Neoingenium Labs SA de CV Hand sanitizer (Mexico) | ProCare Gel | 75810-101-01 | Neoingenium Labs SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/18/2020; FDA issued a warning letter on 3/31/21 | 09/11/2020 |
| Neoingenium Labs SA de CV Hand sanitizer (Mexico) | Hand Sanitizer | 75810-102-01 | Frozen Wheels LLC (Miami) | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/18/2020; FDA issued a warning letter on 3/31/21 | 09/11/2020 |
| Neoingenium Labs SA de CV Hand sanitizer (Mexico) | SafeMedics | 75810-103-01 75810-103-04 75810-103-05 |
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/18/2020; FDA issued a warning letter on 3/31/21 | 09/11/2020 | |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Marvel Spiderman Hand Sanitizer |
74530-046-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Hand Sanitizer Kills Germs |
74530-042-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Hand Sanitizer |
74530-041-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Disney Princess Hand Sanitizer |
74530-015-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Disney Frozen II Hand Sanitizer |
74530-011-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Disney Mickey Mouse Hand Sanitizer |
74530-013-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Disney Mickey Mouse Hand Sanitizer |
74530-013-02 |
Best Brand Consumers Products, Inc. (New York) | FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily recalled lot 20D21 on 4/1/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/02/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations |
74530-012-01 |
Best Brand Consumers Products, Inc. (New York) | Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/09/2022 |
| Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China) | Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations |
74530-012-02 |
Best Brand Consumers Products, Inc. (New York) | FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily recalled lot 20E21 on 4/1/2022; added manufacturer to import alert to help stop their products from entering the U.S. on 4/22/2022 | 03/02/2022 |
|
Ningbo Pasco United Industry Co., Ltd. (China) |
Pasco Instant Hand Sanitizer Aloe & Moisturizers |
52903-001-01 52903-002-01 52903-003-01 52903-004-01 52903-005-01 52903-051-01 52903-052-01 52903-053-01 52903-054-01 52903-055-01 52903-100-01 52903-101-01 52903-201-01 52903-301-01 52903-401-01 52903-501-01 52903-501-91 52903-502-01 52903-502-91 |
The BIGBOND LLC (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
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Ningbo Pasco United Industry Co., Ltd. (China) |
Pasco Alcohol Antiseptic 80% Hand Rub |
59203-500-01 |
The BIGBOND LLC (New Jersey |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
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Ningbo Pasco United Industry Co., Ltd. (China) |
Delma Instant Hand Sanitizer Gel |
80208-111-01 80208-111-02 80208-111-03 80208-111-04 80208-111-05 |
Delma Global Inc. (California) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
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Ningbo Pasco United Industry Co., Ltd. (China)
|
Delma Instant Hand Sanitizer Gel With Aloe Vera |
80208-112-01 80208-112-02 80208-112-03 80208-112-04 |
Delma Global Inc. (California)
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Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
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Ningbo Pasco United Industry Co., Ltd. (China)
|
Pasco Instant Hand Sanitizer Aloe & Moisturizers
|
87052-003-02 87052-004-01 87052-005-01 87052-005-02 87052-007-01 87052-008-01 87052-009-01 87052-010-01 87052-013-01 87052-111-01 87052-115-01 87052-117-01 87052-119-01 |
The BIGBOND LLC (New Jersey) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
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Ningbo Pasco United Industry Co., Ltd. (China) |
Pasco Alcohol Antiseptic 80% Hand Rub |
80752-500-01 |
The BIGBOND LLC (New Jersey)*
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Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022 |
06/08/2022 |
| Notarika SA de CV (Mexico) | Greenfrog Hand Sanitizer | 77031-454-05 77031-454-34 77145-000-01 77145-000-02 |
Notarika SA de CV | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 10/07/2021 | 08/03/2020 |
| Notarika SA de CV (Mexico) | Greenfrog Hand Sanitizing wipes | 77145-001-00 77145-001-01 77145-001-02 77145-001-03 77145-002-03 |
Notarika SA de CV | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 10/07/2021 | 08/03/2020 |
| Noticias Mexico Hoy Grupo Multimedia (Mexico) | Medical Mary Clean Hand Sanitizer | 76839-521-01 76839-521-04 76839-522-03 |
Medical Mary LLC | FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 06/27/2022 | 08/06/2020 |
| Noticias Mexico Hoy Grupo Multimedia (Mexico) | AMX Instant Hand Sanitizer | 76839-523-05 | AMX Premium Cleaning Services LP | Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 06/27/2022 | 08/06/2020 |
| Nutrix International LLC | Heal the World LLC | 73333-285-01 | Heal the World hand sanitizer | Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily recalled on 3/16/2021 | 03/08/2021 |
| Open Book Extracts (North Carolina) | Always Be Clean Hand Sanitizer | 75091-2020-1 75091-2020-2 75091-2020-3 |
Open Book Extracts | Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/29/2020 | 08/11/2020 |
| Open Book Extracts (North Carolina) | Just Hand Sanitizer Single Use Packs | 78065-2020-1 78065-2020-2 |
Just Hand Sanitizer | Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/29/2020 | 08/11/2020 |
| Plasticos Las Palmas SA de CV (Mexico) | BV BYE Virus 99 | 76560-0001-2 76560-0001-3 76560-0001-4 76560-0001-5 76560-0001-6 76560-0001-8 |
Comercial Goura S de RL and S&L Brands | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to import alert to help stop their products from entering the U.S. on 8/6/2020; FDA issued a warning letter on 3/1/2021 | 08/11/2020 |
| Plasticos Las Palmas SA de CV (Mexico) | In Good Hands Hand Sanitizer Gel | 76560-0002-1 76560-0002-2 76560-0002-3 |
Admay Consulting LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/6/2020; FDA issued a warning letter on 3/1/2021 | 08/11/2020 |
| Prairie Wolf Spirits | Prairie Wolf Distillery Hand Sanitizer | 73891-1001-4 73891-1001-5 73891-1002-4 73891-1002-5 |
Prairie Wolf Spirits | Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product recalled on 06/21/2021 | 06/23/2021 |
| Precision Analitica Integral SA de CV (Mexico) | CleanCare Nogerm Advanced Hand Sanitizer | 77492-006-25 77492-007-01 77492-008-50 77492-009-05 |
ESPMEX LLC | FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/5/2021 | 08/07/2020 |
| Quimica Magna de Mexico SA de CV (Mexico) | Datsen Hand Sanitizer | Not listed | FDA tested product; ethyl alcohol level was subpotent; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020 | 08/03/2020 | |
| Quimica Magna de Mexico SA de CV (Mexico) | Alcohol Antiseptic 62% Hand Sanitizer | 74844-162-02 74844-162-08 74844-162-17 74844-162-34 |
Quimica Magna de Mexico SA de CV | FDA tested product; ethyl alcohol level was subpotent; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020 | 08/03/2020 |
| Quimica Magna de Mexico SA de CV (Mexico) | Bernal Hand Sanitizer | 74541-270-01 74541-270-02 74541-270-04 74541-270-06 74541-270-08 74541-270-17 74541-270-34 74541-270-37 |
Inflatables LLC | Product purported to be made at the same facility that produced subpotent product; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020 | 08/03/2020 |
| Quimica Magna de Mexico SA de CV (Mexico) | Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer | 74844-165-02 74844-165-08 74844-165-17 74844-165-34 74844-170-02 74844-170-08 74844-170-17 74844-170-34 |
Inflatables LLC | Product purported to be made at the same facility that produced subpotent product; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020 | 08/03/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Born Basic. Anti-Bac Hand Sanitizer 70% alcohol | 76891-104-11 76891-104-12 76891-104-13 76891-104-14 76891-104-15 76891-104-16 76891-104-17 76891-104-18 76891-104-19 73389-104-11 |
Scent Theory Products LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Born Basic. Anti-Bac Hand Sanitizer 65% Alcohol | 76891-105-11 76891-105-12 76891-105-13 76891-105-14 76891-105-15 76891-105-16 76891-105-17 76891-105-18 76891-105-19 76891-105-20 |
Scent Theory Products LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer | 76891-102-11 | Scent Theory Products LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Cavalry (labeled with “Product of Mexico”) | 75460-070-01 75460-070-02 75460-070-05 |
Cavalry Sanitizers LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | ENLIVEN Hand Sanitizing Gel | 74882-341-01 74882-341-02 74882-341-03 |
Procurement Services LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Lux Eoi Hand Sanitizing Gel | 74882-007-01 74882-007-02 74882-007-03 |
Procurement Services LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Real Clean Distribuciones SA de CV (Mexico) | Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer | 73389-102-11 | Scent Theory Products Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020; FDA issued a warning letter on 10/27/2020 | 07/14/2020 |
| Rodriguez Fierro, Marco Antonio (Mexico) | Natural Gold Gel Alcohol Antiseptic 75% Topical Solution | 78368-567-12 | Dist. de Prod. Alim. El Paisita | FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/28/2020 | 09/17/2020 |
| Roque Plast SA de CV (Mexico) | Command Gel AntiBac Instant hand sanitizer | 50058-100-08 | Roque Plast SA de CV | FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily recalled 8/4/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 4/9/2021 | 08/03/2020 |
|
S-One Pharmaceutical Inc |
Safe Cleaner Hand Sanitizer Gel |
74721-0001-1 |
S-ONE Pharmaceutical Inc. (Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-One Pharmaceutical Inc |
Safe Cleaner K |
74721-0050-1 |
S-ONE Pharmaceutical Inc. (Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-ONE Pharmaceutical Inc. (Korea) |
PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose) |
80969-006-01 |
Stronghold Trading, LLC |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-ONE Pharmaceutical Inc. (Korea) |
PFA Protection For All Hand Sanitizer |
80969-010-01 |
Stronghold Trading, LLC |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-ONE Pharmaceutical Inc. (Korea) |
PFA Stronghold Hand Sanitizer |
80969-030-02 |
Stronghold Trading, LLC |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-ONE Pharmaceutical Inc. (Korea) |
NYC HEALTH HOSPITALS HAND SANITIZER |
80969-050-01 |
Stronghold PFA |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
|
S-ONE Pharmaceutical Inc. (Korea) |
Safe Cleaner Plus |
74721-0010-1 |
S-ONE Pharmaceutical Inc. (Korea) |
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022 |
06/29/2022 |
| Santa Cruz Biotechnology (Texas) | UltraCruz Hand Sanitizing Gel Antimicrobial | 90032-214-08 90032-214-83 90032-214-94 |
Santa Cruz Biotechnology | Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020 | 08/11/2020 |
| Sanit Technologies LLC, doing business as Durisan (Florida) | Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free |
71120-112-01 |
Sanit Technologies LLC, dba Durisan | Company tested product; contains microbial contamination; product recalled to wholesale level on 3/24/2021; recall expanded on 4/10/2021; recall expanded on 5/14/2021; recall expanded on 06/19/2021 | 03/25/2021 |
| Sanit Technologies LLC, doing business as Durisan (Florida) | Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free | 71120-111-01 71120-111-02 71120-111-03 |
Sanit Technologies LLC, dba Durisan | Company tested product; contains microbial contamination; product recalled on 3/24/2021; recall expanded on 4/10/2021; recall expanded on 5/14/2021; recall expanded on 06/19/2021 | 05/19/2021 |
| Sanitor Corporation (California) | New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) | 80042-003-00 | New Wave Cleaning Solutions LLC | Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. FDA recommended the company recall on 9/20/2021; product voluntarily recalled on 9/21/2021 | 09/22/2021 |
| SBL Brands LLC dba Global Sanitizers, LLC (Nevada) | American Screening HAND SANITIZER | Not listed | American Screening, LLC | Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a warning letter on 11/08/2021. product voluntarily recalled on 11/19/2021 | 09/29/2021 |
| Scentsational Soaps and Candles Inc. (Florida) | Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution | 75078-002-01 75078-003-01 75078-004-01 |
Scentsational Soaps and Candles Inc. | Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily recalled on 4/28/2021; recall expanded on 5/10/2021 | 04/29/2021 |
| Scentsational Soaps and Candles Inc. (Florida) | Fresh Lemon Citron Frais Scented Hand Sanitizer | Not Listed | Ulta Beauty | Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily recalled on 4/28/2021; recall expanded on 5/10/2021 | 05/03/2021 |
| Scentsational Soaps and Candles Inc. (Florida) | SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava | Not Listed | Scentsational Soaps and Candles Inc. | Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily recalled on 4/28/2021; recall expanded on 5/10/2021 | 05/03/2021 |
| Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey) | Neutrevo Instant Hand Sanitizer | 86818-002-06 | Leather Links Inc. | FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/22/2020; FDA issued a warning letter on 07/15/2021 | 09/11/2020 |
| Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey) | Neutrevo Instant Hand Sanitizer | 86818-002-05 86818-002-07 86818-002-08 |
Leather Links Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/22/2020; FDA issued a warning letter on 07/15/2021 | 09/11/2020 |
| Sck Zeta Zimya (Turkey) | Neutrevo Alcohol Wet Wipes | 86818-005-01 86818-005-02 86818-005-03 86818-005-04 86818-005-05 86818-005-06 |
Sck Zeta Dis Ticaret Pazarlama Ltd. | Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/22/2020; FDA issued a warning letter on 07/15/2021 | 09/11/2020 |
| SG24 LLC (Georgia) | SkinGuard24 All-Day Hand Sanitizer | Not listed | Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020 | 08/11/2020 | |
| Shuzy Rock, Inc. (New Jersey) | Premium Nature Instant Hand Sanitizer |
75821-001-01 |
Premium Nature | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022 | 01/24/2022 |
| Signature Formulations, LLC (Arizona) | Sigform Cares Hand Sanitizer | Not Listed | Signature Formulations, LLC (Arizona) | Company tested product; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022 Associated lot numbers: 200401143; 200406143; 200414145; 200415145; 200422145; 200522148; 200611145. |
04/13/2022 |
| Signature Formulations, LLC (Arizona) | BIOLabs PRO Killshot Hand Sanitizer | Not Listed | Signature Formulations, LLC (Arizona) | Company tested product lot 200423322; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. | 04/13/2022 |
| Signature Formulations, LLC (Arizona) | Cultivation Republic Hand Sanitizer | Not Listed | Cultivation Republic (Clearwater, Florida) | Company tested product lot 2004090090; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. | 04/13/2022 |
| Simex Logistics SA de CV (Mexico) | Health & Hand Gel Hand Sanitizer | 78247-006-01 | Blue Ridge Southern Supply LLC | FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Simex Logistics SA de CV (Mexico) | Health & Hand Gel Hand Sanitizer | 78247-007-10 | Blue Ridge Southern Supply LLC | Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Simex Logistics SA de CV (Mexico) | LAVAR70 Gel Hand Sanitizer | 78247-001-01 | Blue Ridge Southern Supply LLC | Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Simex Logistics SA de CV (Mexico) | CitruGel Hand Sanitizer | 78247-002-01 | CitruGel Inc. | Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Simex Logistics SA de CV (Mexico) | UVTWORLD Gel Hand Sanitizer | 78247-003-01 | UVT World | Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Simex Logistics SA de CV (Mexico) | Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution | 78247-004-01 78247-005-05 78247-008-10 |
PS Promotional Services LLC | Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a warning letter on 1/28/2021 | 11/10/2020 |
| Soleo Cosmetic Co. Ltd. (Korea) | Smart Care hand sanitizer packaged in 0.84 fl oz. containers resembling food pouches labeled with children’s characters, including Barbie, Hot Wheels, Paw Patrol, Minions, JoJo Siwa Dreamer and Trolls World Tour | 70108-042-01 71693-007-01 70108-043-01 71693-008-01 70108-044-01 71693-004-01 70108-045-01 71693-005-01 70108-046-01 71693-006-01 70108-047-01 71693-009-01 |
Ashtel Studios Inc. | Hand sanitizer products packaged in containers resembling food pouches commonly used for children’s applesauce and other pureed foods that present increased risk of accidental ingestion by children; FDA recommended the distributor recall on 9/21/2020; this advisory does not extend to Smart Care products in other types of packaging; product voluntarily recalled by Ashtel on 10/1/2020 (includes product photos) | 09/24/2020 |
| Spartan Chemical Co Inc. (Ohio) | Lite ’n Foamy Lemon Blossom Hand Sanitizer | 64009-331-82 64009-331-85 64009-331-88 |
Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020 and on 3/29/2021; FDA issued a warning letter on 12/15/2021 | 08/03/2020 | |
| Spartan Chemical Co Inc. (Ohio) | foamyiQ Lemon Blossom Hand Sanitizer | 64009-202-06 | Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020; FDA issued a warning letter on 12/15/2021 | 08/03/2020 | |
| Soluciones Cosmeticas SA de CV (Mexico) | Bersih Hand Sanitizer Gel Fragrance Free | 75165-000-01 75165-001-01 75165-003-02 75165-004-01 75165-005-01 75165-006-01 75165-250-01 |
Private D Capital Group Corp., Human Choice LLC and RediBag USA Astrum LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; product voluntarily recalled on 7/14/2020 and updated the recall on 8/9/2020; FDA issued a warning letter on 8/4/2020 | 07/02/2020 |
| Soluciones Cosmeticas SA de CV (Mexico) | Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer | 75165-600-01 | Astrum LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020 | 07/02/2020 |
| Soluciones Cosmeticas SA de CV (Mexico) | Purity Advanced Hand Sanitizer | 75165-008-01 | Human Choice LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020 | 07/02/2020 |
| Soluciones Cosmeticas SA de CV (Mexico) | Hand Sanitizer Gel Alcohol 70% | 79095-000-01 79095-001-01 79095-002-01 79095-003-01 79095-004-01 79095-005-01 79095-006-01 |
Wet Look Janitorial and Gardening Corp. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020 | 07/10/2020 |
| Southwest Iowa Renewable Energy (Iowa) |
SIREtizer Alcohol Antiseptic 80% Topical Solution Hand Sanitizer | 74560-001-01 74560-001-02 74560-001-03 74560-001-04 74560-001-05 |
Southwest Iowa Renewable Energy | FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 09/27/2022; product voluntarily recalled on 9/27/2022. | 11/23/2022 |
| Team Bg and Associates L.M.A., Inc. (Louisiana) |
First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75% | 76952-946-32 | Team Bg and Associates L.M.A., Inc. (Louisiana) |
FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. | 11/23/2022 |
| Tropicosmeticos SA de CV (Mexico) | Britz Hand Sanitizer Ethyl Alcohol 70% | 76676-402-01 76676-402-02 76676-402-14 |
Soflo Urban Team LLC | FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Parabola Hand Sanitizer | 76676-402-03 76676-402-09 |
Soflo Urban Team LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Urbane Bath and Body Hand Sanitizer | 76676-402-04 | Liberty International Distributors | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Cleaner Hand Sanitizer Rinse Free 70% | 76676-402-07 76676-402-08 |
Liberty International Distributors | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Handzer Hand Sanitizer Rinse Free | 76676-402-10 76676-402-11 |
Liberty International Distributors | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Kleanz Antibacterial Hand Sanitizer Advanced | 76676-402-05 76676-402-06 76676-402-12 76676-402-13 |
Up in the Lab | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Be Safe Hand Sanitizer (labeled with “Model: BF-HGXXXX-09” where XXXX changes based on packaging size) | 76676-402-16 76676-402-17 76676-402-18 76676-402-19 |
BeSafe Industries LLC | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA has no evidence of U.S. distribution of Be Safe Hand Sanitizer manufactured by Tropicosmeticos; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
| Tropicosmeticos SA de CV (Mexico) | Wave Hand Sanitizer Gel | 76676-402-20 | C&A Marketing Inc. | Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/10/2021 | 07/02/2020 |
|
True Chemical Solutions, LLC (Texas) |
Hand Sanitizer B, Hand Sanitizer C, Hand Sanitizer E, Hand Sanitizer G |
77991-000-00 77991-001-00 77991-002-00 77991-003-00 |
True Chemical Solutions, LLC (Texas) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/29/2021. | 11/10/2021 |
| Unknown | artnaturals Scent Free Hand Sanitizer Natural Elements + Cleansing Formula 8 fl oz (236ml) |
Unable to determine | Virgin Scents dba artnaturals (Gardena, CA) | FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily recalled on 10/26/2021; scope of overall contamination still under investigation; FDA issued a warning letter on 08/17/2022 and a warning letter on 09/01/2022. | 10/04/2021 |
| Unknown | “hand sanitizer” | Not Listed | CES LLC. (Nevada) | Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as “hand sanitizer” and “Distributed by: CES LCC 7322 S. Rainbow Blvd. Suite #166 Las Vegas, NV 89139" FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product | 09/29/2021 |
| Unknown | “hand sanitizer” | Not Listed | Chambers & Owen, Inc. | Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as “hand sanitizer” and “Distributed by: CES LCC 7322 S. Rainbow Blvd. Suite #166 Las Vegas, NV 89139"; FDA recommended the company recall on 11/3/2021; product voluntarily recalled on 11/4/2021 | 11/10/2021 |
| Unknown | Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer | Not Listed | SBL Brands LLC dba Global Sanitizers LLC (Nevada) | FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily recalled on 5/12/2021; recall expanded on 5/20/2021; FDA issued a warning letter on 11/08/2021 | 12/30/2020 |
| Unknown | Medically Minded Hand Sanitizer Gel Anitmicrobial Formula | 76619-110-01 76619-110-03 76619-110-04 76619-110-05 76619-110-06 76619-110-07 76619-110-08 76619-110-09 76619-120-02 |
SBL Brands LLC dba Global Sanitizers LLC (Nevada) | Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily recalled on 5/12/2021; recall expanded on 5/20/2021; FDA issued a warning letter on 11/08/2021 | 12/30/2020 |
| Unknown | Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer | 60717-803-04 | SBL Brands LLC dba Global Sanitizers LLC (Nevada) | Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily recalled on 5/12/2021; recall expanded on 5/20/2021; FDA issued a warning letter on 11/08/2021 | 12/30/2020 |
| Volu-Sol Inc. (Utah) | Volu-Sol Handrub Sanitizing Solution | 74401-800-16 74401-800-32 |
Volu-Sol | Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020 | 08/11/2020 |
| Welburn Global Sociedad Anonima (Guatemala) | Happy Hands Hand Sanitizer |
77991-004-01 77991-004-02 77991-004-03 77991-004-04 77991-004-05 77991-004-06 |
True Chemical Solutions, LLC (Texas) | Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/29/2021. | 11/10/2021 |
| Yara Elena de La Garza Perez Nieto (Mexico) | DAESI Hand Sanitizer | 77268-001-01 | Yara Elena de La Garza Perez Nieto | FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/17/2020; ; FDA issued a warning letter on 2/22/2021 | 07/10/2020 |
| Yangzhou Olande Cosmetic Co. Ltd (China) | Leafree Instant Hand Sanitizer | 75717-001-01 | CorgioMed LLC | Product labeled to be “edible alcohol”; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA recommended a recall to the distributor on 9/1/2020; product voluntarily recalled by CorgioMed LLC on 9/3/2020 | 08/11/2020 |
Historical References:
[10/12/2021] Go to FDA in Brief
[10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntary recall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer.
[10/4/2021] FDA has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248” and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the list of hand sanitizers consumers should not use.
To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers.
Benzene may cause certain types of cancer in humans. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. Acetal can irritate the upper respiratory tract, eyes, and skin. While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal.
Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
[3/25/2021] FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.
Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. Individuals with compromised immune systems are at increased risk. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization.
The agency has updated its do-not-use list of hand sanitizers to include Durisan’s contaminated hand sanitizers.
Durisan’s hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Consumers who have products on the list of hand sanitizers with potential contamination should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA is not aware of any adverse events related to Durisan’s hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
Go to FDA Press Release
[1/19/2021] Today, FDA issued a guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDA’s temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic.
However, consistent with FDA’s temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source.
The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. Ethanol used to manufacturer hand sanitizer products under FDA’s temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies.
The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol.
The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers.
Go to FDA Press Release
[8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDA’s temporary guidances.
Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. USP’s revision bulletin for alcohol and dehydrated alcohol monographs outlines this testing requirement, official as of September 1, 2020, which FDA requested to protect health care providers and consumers from using dangerous hand sanitizer products.
The agency’s investigation of contaminated hand sanitizers is ongoing.
[8/12/2020] FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.
Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported.
Consumers who have products on the list of hand sanitizers with potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.
The agency continues to add certain hand sanitizers to the import alert to stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
[8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination.
FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).
Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.
The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities.
The agency also included an additional denaturant formula in the temporary guidances. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care professional safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply.
For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov.
[7/31/2020] FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol
The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19.
FDA encourages health ce professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
Go to FDA Press Release
[7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.
The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.
Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.
Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:
- The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
- Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
- Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
- Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
- Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
- Products labeled with harmful or poisonous ingredients, such as methanol.
FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
Go to FDA Press Release