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FDA updates on hand sanitizers consumers should not use

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Hand sanitizers consumers should not use

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[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):

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

[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):

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178

FDA urges consumers not use certain hand sanitizer products

The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that:

  • Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal.
  • Is labeled to contain methanol.
  • Has been tested and is found to have microbial contamination.
  • Is being recalled by the manufacturer or distributor.
  • Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.
  • Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal.
  • Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion.
  • Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process.

 

FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. Consumers can easily identify which hand sanitizer products to avoid by using the following information:

  • 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.

Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Consumers should be aware that FDA’s recommendation against using a distributor’s specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to:

  • A distributor’s products bearing the same brand name as listed below, but made by a different manufacturer
  • Other products distributed by the same distributor

If a product on the list below does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product.

For more information, visit Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?

Manufacturer Product(s) NDC(s) Distributor Product Status Date added to table
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
75339-751-02
75339-751-03
75339-751-04
75339-751-05
75339-751-06

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

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. 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. 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. 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. 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. 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 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 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 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

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

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

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

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

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.

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.

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.

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

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

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.

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

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.

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

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

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

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

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 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

75010-030-01

75010-050-01

75010-060-01

75010-070-01

75010-080-01

75010-090-01

75010-110-01

75010-120-01

The Creme 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

75010-040-01

75010-140-01

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

75010-150-02

75010-150-03

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

74443-010-50

74443-020-05

74443-020-50

74443-030-01

74443-030-05

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
74530-015-02
74530-015-03
74530-015-04
74530-015-05
74530-015-06

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
74530-011-02
74530-011-03
74530-011-04
74530-011-05
74530-011-06
74530-011-07
74530-011-08

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
74530-013-03
74530-013-04
74530-013-05
74530-013-06
74530-013-07
74530-013-08

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
74530-012-03
74530-012-04
74530-012-05
74530-012-06
74530-012-07
74530-012-08

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

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

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

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)

 

Product manufactured at a facility that did not respond to multiple FDA requests for 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

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

Ningbo Pasco United Industry Co., Ltd. (China)

Pasco Alcohol Antiseptic 80% 

Hand Rub

80752-500-01

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

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 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 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
(Korea)

Safe Cleaner Hand Sanitizer Gel
Sophora Extract
Mint Oil
Grapefruit Extract

74721-0001-1
74721-0001-2
74721-0001-3
74721-0001-4
74721-0001-5
74721-0001-6
74721-0001-7
74721-0001-8
74721-0001-9
74721-0001-0
74721-0002-1
74721-0002-2
74721-0002-3
74721-0002-4
74721-0002-5
74721-0002-6
74721-0002-7
74721-0002-8
74721-0002-9

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.

06/29/2022

S-One Pharmaceutical Inc
(Korea)

Safe Cleaner K
Disinfection Spray Chlorine Dioxide Ion (1-)

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.

06/29/2022

S-ONE Pharmaceutical Inc. (Korea)

PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose)

80969-006-01
80969-007-01
80969-008-01

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.

06/29/2022

S-ONE Pharmaceutical Inc. (Korea)

PFA Protection For All Hand Sanitizer

80969-010-01
80969-010-02
80969-010-06
80969-010-07
80969-020-03
80969-020-04
80969-040-03
80969-040-04

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.

06/29/2022

S-ONE Pharmaceutical Inc. (Korea)

PFA Stronghold Hand Sanitizer
Alcohol Free Disinfectant

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.

06/29/2022

S-ONE Pharmaceutical Inc. (Korea)

NYC HEALTH HOSPITALS HAND SANITIZER

80969-050-01
80969-050-02

Stronghold PFA

Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.

06/29/2022

S-ONE Pharmaceutical Inc. (Korea)

Safe Cleaner Plus
Sophora Extract
Mint Oil
Grapefruit Extract

74721-0010-1
74721-0010-2
74721-0010-4
74721-0010-5
74721-0010-6
74721-0010-7
74721-0010-8
74721-0010-9
74721-0020-0
74721-0020-1
74721-0020-2
74721-0020-5
74721-0020-6
74721-0020-7
74721-0020-8
74721-0020-9

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.

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
71120-112-05
71120-112-06
71120-112-08
71120-112-10
71120-112-11
71120-611-07
71120-611-08
71120-612-06
71120-612-07
71120-117-02

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
75821-001-02
75821-001-03
75821-001-04
75821-002-01
75821-002-02
75821-002-03

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
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.  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
 

Notice to manufacturers and distributors: If you believe your products do not meet the criteria for inclusion on this list, please provide your reasoning and supporting information for our consideration to HSDoNotUseListInquiries@fda.hhs.gov.

 

 

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