U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA updates on hand sanitizers consumers should not use
  1. Drug Safety and Availability

FDA updates on hand sanitizers consumers should not use

Hand sanitizers consumers should not use

Spanish version

[8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination.

FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).

Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.

The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities.

The agency also included an additional denaturant formula in the temporary guidances. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care professional safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply.

For questions, contact FDA:  COVID-19-Hand-Sanitizers@fda.hhs.gov.

[7-2-2020] 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’s 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.
  • 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.

FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.

Manufacturer

Distributor

Date added to table

Product(s)

NDC(s)

Product status

4E Global SAPI de CV (Mexico)

 

07/08/2020

Blumen Clear Advanced Hand Sanitizer with 70% Alcohol

Not listed

FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

 

07/08/2020

Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%

Not listed

FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Instant Hand Sanitizer Clear

60599-015-00

FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Instant Hand Sanitizer Clear

60599-015-01

60599-015-02

FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/11/2020

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

KLAR AND DANVER Instant Hand Sanitizer

33992-8010-1

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

Midwood

Brands LLC

07/08/2020

MODESA Instant Hand Sanitizer Moisturizers and Vitamin E

60599-007-33

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Hand Sanitizer

60599-012-04

60599-012-08

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 to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

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

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Hand Sanitizer Aloe

60599-013-00

60599-013-01

60599-014-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Instant Hand Sanitizer Lavender

60599-016-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear Advanced Hand Sanitizer

60599-018-02

60599-018-04

60599-018-06

60599-018-07

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear Advanced Hand Sanitizer

60599-017-00

60599-018-00

60599-018-01

60599-018-02

60599-018-04

60599-018-06

60599-018-07

 

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 to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear LEAR Advanced Hand Sanitizer

60599-017-00

60599-018-01

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear LEAR Advanced Hand Sanitizer

60599-017-01

60599-018-00

60599-018-03

60599-018-05

60599-018-08

60599-019-00

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

The Honeykeeper Hand Sanitizer

60599-020-00

60599-020-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Advanced Hand Sanitizer Clear

60599-024-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear Advanced Instant Hand Sanitizer

60599-025-00

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear Advanced Instant Hand Sanitizer Aloe

60599-026-00

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Clear Advanced Instant Hand Sanitizer Lavender

60599-027-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol

60599-028-00

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 to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol

60599-029-00

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 to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol

60599-046-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol

60599-047-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

Blumen Antibacterial Fresh Citrus Hand Sanitizer

60599-501-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

Blumen Hand Sanitizer Fresh Citrus

60599-502-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

KLAR and DANVER Instant Hand Sanitizer

60599-801-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

Hello Kitty Hand Sanitizer

60599-802-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

Assured Instant Hand Sanitizer (Vitamin E and Aloe)

60599-850-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

Assured Instant Hand Sanitizer (Aloe and Moisturizers)

60599-851-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

Assured Instant Hand Sanitizer Vitamin E and Aloe

60599-852-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

Assured Instant Hand Sanitizer Aloe and Moisturizers

60599-853-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Instant Hand Sanitizer Fragrance Free

60599-854-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

4E Brands North America LLC

07/08/2020

BLUMEN Instant Hand Sanitizer Aloe Vera

60599-855-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

4E Global SAPI de CV (Mexico)

Greenbrier International Inc.

07/08/2020

Assured Aloe

60599-999-10

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers

AAA Cosmetica (Mexico)

Payless Janitorial Corporation

07/06/2020

bio aaa Advance Hand Sanitizer 

76987-402-01

74840-402-01

FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added to import alert to stop products from entering the U.S. on 7/7/2020; product voluntarily recalled on 7/14/2020

AAA Cosmetica (Mexico)

Soflo Urban Team LLC

07/06/2020

LumiSkin Advance Hand Sanitizer

76987-120-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added to import alert to stop products from entering the U.S. on 7/7/2020

AAA Cosmetica (Mexico)

Soflo Urban Team LLC

07/06/2020

LumiSkin Advance Hand Sanitizer

76987-402-02

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added to import alert to stop products from entering the U.S. on 7/7/2020

AAA Cosmetica (Mexico)

QualitaMed Corp.

07/06/2020

QualitaMed Hand Sanitizer  

76987-250-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added to import alert to stop products from entering the U.S. on 7/7/2020

Albek de Mexico SA de CV (Mexico)

Genomma Lab USA

07/28/2020

NEXT Hand Sanitizer

50066-605-08

FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily recalled on 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

NuuxSan Instant Antibacterial Hand Sanitizer

72758-001-08

72758-002-08

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

NuuxSan Instant Hand Sanitizer

72758-003-00

72758-003-01

72758-005-01

72758-005-02

72758-005-03

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers

72758-009-23

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe

72758-010-23

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera

72758-011-23

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Albek de Mexico SA de CV (Mexico)

Albek de Mexico SA de CV

07/28/2020

Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E

72758-012-23

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 7/30/2020; added to import alert to stop products from entering the U.S. on 8/4/2020

Asiaticon SA de CV (Mexico)

Astrum LLC

08/06/2020

V-KLEAN Hand Sanitizer Gel

Not listed

FDA tested product; ethanol alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

Asiaticon

08/06/2020

V-KLEAN Hand Sanitizer Gel

75192-001-01

75192-002-04

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

Acadia Mercantil Corp.

08/06/2020

V-KLEAN Hand Sanitizer Gel

75192-002-01

75192-002-02

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

Protex Labs

08/06/2020

V-KLEAN Hand Sanitizer Gel

75192-002-03

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

Protex Labs

08/06/2020

Derma70 Hand Sanitizer

75192-003-01

75192-003-02

75192-003-03

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

SWCH LLC

08/06/2020

V-KLEAN

75192-100-01

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

SBL Brands

08/06/2020

Medically Minded Hand Sanitizer Gel

75192-500-01

75192-600-01

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Asiaticon SA de CV (Mexico)

Safety-Med Products

08/06/2020

Protz Real Protection Antibacterial Hand Sanitizer

75192-600-02

Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 8/11/2020

Botanicals Internacional SA de CV (Mexico)

Pure Haven

08/06/2020

Alcohol Antiseptic 80% topical solution hand sanitizer

51384-001-01

51384-001-02

FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market

Botanicals Internacional SA de CV (Mexico)

Inambtec SA de CV

08/06/2020

Inatek Hand Sanitizer Non-Sterile Solution

70% of Alcohol

51384-002-01

FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; FDA has no evidence this product is in the U.S. market

Botanicals Internacional SA de CV (Mexico)

Good Fibers LLC

08/06/2020

All Clear Hand Sanitizer Fragrance Free

51384-004-01

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

Botanicals Internacional SA de CV (Mexico)

 

08/06/2020

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

Botanicals Internacional SA de CV (Mexico)

USMed Supplies LLC

08/06/2020

70% Alcohol Gel Hand Sanitizer

51384-500-10

51384-500-11

51384-500-23

51384-500-47

51384-500-94

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

Botanicals Internacional SA de CV (Mexico)

Quick Aid LLC

08/06/2020

ResQue 1st Instant Hand Sanitizer

73762-100-10

73762-100-11

73762-100-23

73762-100-47

73762-100-94

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

Botanicals Internacional SA de CV (Mexico)

LTD Enterprises Distribution

08/06/2020

70% Alcohol Gel Hand Sanitizer

78072-400-10

78072-400-11

78072-400-23

78072-400-47

78072-400-94

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

Botanicals Internacional SA de CV (Mexico)

USMed Supplies LLC

08/06/2020

70% Alcohol Gel Hand Sanitizer

78072-500-10

78072-500-11

78072-500-23

78072-500-47

78072-500-94

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

Broncolin SA de CV (Mexico)

INBC Trading LLC

07/24/2020

Herbacil Antiseptic Hand Sanitizer 70% Alcohol

62583-020-08

FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added to import alert to stop products from entering the U.S. on 7/29/2020

Broncolin SA de CV (Mexico)

INBC Trading LLC

07/24/2020

Herbacil Antiseptic Hand Sanitizer 70% Alcohol

62583-020-16

62583-020-33

62583-020-42

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 to import alert to stop products from entering the U.S. on 7/29/2020

Broncolin SA de CV (Mexico)

INBC Trading LLC

07/24/2020

Herbacil Antiseptic Hand Sanitizer 70% Alcohol

74673-001-08

74673-001-16

74673-001-33

74673-001-42

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 to import alert to stop products from entering the U.S. on 7/29/2020

DDI Multinacional SA de CV (Mexico)

Earths Amenities

07/08/2020

Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced

74949-002-20

74949-002-25

74949-002-49

74949-002-60

FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall on all other potential products on the market on 6/29/2020; added to import alert to stop products from entering the U.S. on 7/13/2020

DDI Multinacional SA de CV (Mexico)

Vidanos Easy Cleaning Rentals

07/08/2020

Hand Sanitizer Agavespa Skincare

77415-000-00

FDA tested product; contains methanol; FDA recommended the company recall on other all potential products on the market on 6/29/2020; added to import alert to stop products from entering the U.S. on 7/13/2020

DDI Multinacional SA de CV (Mexico)

Vidanos Easy Cleaning Rentals

07/08/2020

Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare

77056-000-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on all other potential products on the market on 6/29/2020; added to import alert to stop products from entering the U.S. on 7/13/2020

DEPQ Internacional S de RL de CV (Mexico)

Biokaab Inc.

08/03/2020

dgreen Advanced Sanitizer Alcohol Free

74155-211-04

74155-211-07

74155-211-08

74155-211-19

74155-211-20

74155-211-38

FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added to import alert to stop products from entering the U.S. on 7/31/2020

DEPQ Internacional S de RL de CV (Mexico)

Biokaab Inc.

08/03/2020

dgreen Advanced Hand Sanitizer Antibacterial Gel

74155-201-03

74155-201-19

74155-201-20

74155-201-38

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 to import alert to stop products from entering the U.S. on 7/31/2020

DEPQ Internacional S de RL de CV (Mexico)

Biokaab Inc.

08/03/2020

Hand Sanitizer

74155-111-07

74155-111-08

74155-111-19

74155-111-20

74155-111-38

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 to import alert to stop products from entering the U.S. on 7/31/2020

DEPQ Internacional S de RL de CV (Mexico)

Biokaab Inc.

08/03/2020

Hand Sanitizer Gel

74155-101-07

74155-101-08

74155-101-19

74155-101-20

74155-101-38

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 to import alert to stop products from entering the U.S. on 7/31/2020

DEPQ Internacional S de RL de CV (Mexico)

 

08/03/2020

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 to import alert to stop products from entering the U.S. on 7/31/2020

Eskbiochem SA de CV (Mexico)

ESPMEX LLC

07/02/2020*

CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol

74589-009-01

FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

Blue Ridge Southern Supply LLC

07/02/2020*

Lavar 70 Gel Hand Sanitizer

74589-006-01

FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

All Clean Natural LTD

07/02/2020*

All-Clean Hand Sanitizer

74589-002-01

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

EskBiochem

07/02/2020*

Esk Biochem Hand Sanitizer

74589-007-01

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

EskBiochem SA de CV

07/02/2020*

The Good Gel Antibacterial Gel Hand Sanitizer

74589-010-10

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

ESPMEX LLC

07/02/2020*

CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol

74589-005-03

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

ESPMEX LLC

07/02/2020*

CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol

74589-003-01

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Eskbiochem SA de CV (Mexico)

Polarized LLC

07/02/2020*

Saniderm Advanced Hand Sanitizer

74589-001-01

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 to import alert to stop products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/2020

Estrategia Hospitalaria SA DE CV (Mexico)

Ancorp Capital Group USA

08/06/2020

OZO Hand Sanitizer, Luxury Formula

Not listed

FDA tested product; contains methanol; ethanol alcohol level was subpotent; FDA recommended the company recall on 8/5/2020

Grupo Insoma S.A.P.I de CV (Mexico)

Grupo Insoma, S.A.P.I de CV

07/02/2020

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

FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Grupo Insoma S.A.P.I de CV (Mexico)

CIRG Waste & Recycling Solutions US LLC

08/06/2020

Hand sanitizer Gel Unscented 70% Alcohol

Not listed

FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Grupo Plast Y Kosas Sa De CV

(Mexico)

Medek LLC

08/11/2020

M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer

75432-001-02

FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added to import alert to stop products from entering the U.S. on 8/11/2020

Grupo Plast Y Kosas Sa De CV (Mexico)

Medek LLC

08/11/2020

Hand Sanitizer Alcohol Antiseptic topical solution 80%

77797-001-01

75432-001-01

 

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 to import alert to stop products from entering the U.S. on 8/11/2020

Grupo Plast Y Kosas Sa De CV

(Mexico)

 

Medek LLC

08/11/2020

Jalisco Paper Inc Restaurant Supplies Hand Sanitizer

77797-001-02

75432-001-03

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 to import alert to stop products from entering the U.S. on 8/11/2020

Grupo Plast Y Kosas Sa De CV

(Mexico)

 

Medek LLC

08/11/2020

O.K. Pharmacy Hand Sanitizer

77797-001-03

75432-001-04

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 to import alert to stop products from entering the U.S. on 8/11/2020

Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico)

Healthy Food and Nutrition Lab

07/30/2020

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

FDA tested product; ethanol alcohol level was subpotent; FDA recommended the company recall on 7/28/2020

Incredible Products SA de CV (Mexico)

Pacific Coast Global Inc. and Tritanium Labs LLC

07/30/2020

GelBac T

Hand Sanitizer

71761-000-00

FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily recalled on 8/6/2020

Incredible Products SA de CV (Mexico)

Pacific Coast Global Inc. and Tritanium Labs LLC

07/30/2020

Hand Sanitizer

71761-000-01 71761-000-05 71761-000-10 71761-000-20 71761-000-22 71761-000-37 71761-000-99

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020

Incredible Products SA de CV (Mexico)

Tritanium Labs LLC

07/30/2020

TriCleanz

(Labeled with “Made in Mexico”)

71761-001-00

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020

Ismar Soluciones Dinámicas S de RL de CV (Mexico)

Ancorp Capital Group USA

08/06/2020

OZO Hand Sanitizer

Not listed

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

JG Atlas Comercios SA de CV (Mexico)

JG Atlas Comercios

07/30/2020

Sayab Antisepctic Hand Sanitizer 100

75292-001-00

FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added to import alert to stop products from entering the U.S. on 8/7/2020

Laboratorios Jaloma SA de CV (Mexico)

Laboratorios Jaloma SA de CV

7/24/2020

Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E

65055-600-00

65055-600-01

65055-600-02

FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 7/31/2020; added to import alert to stop products from entering the U.S. on 8/3/2020

Leiper’s Fork Distillery (Tennessee)

 

7/24/2020

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

Limpo Quimicos SA de CV

(Mexico)

Brand Name Distributors

07/08/2020

Andy’s Best

73755-120-01

73755-120-02

73755-120-04

 

FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added to import alert to stop products from entering the U.S. on 7/15/2020

Limpo Quimicos SA de CV

(Mexico)

Brand Name Distributors

07/08/2020

Andy’s

73755-110-01

73755-130-02

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added to import alert to stop products from entering the U.S. on 7/15/2020

Limpo Quimicos SA de CV

(Mexico)

Brand Name Distributors

07/08/2020

NeoNatural

73755-200-01

73755-200-02

FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added to import alert to stop products from entering the U.S. on 7/15/2020

Limpo Quimicos SA de CV

(Mexico)

Brand Name Distributors

07/08/2020

Plus Advanced

73755-300-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added to import alert to stop products from entering the U.S. on 7/15/2020

Liqesa Exportacion or Liq-E-S.A. de CV (Mexico)

Liq-E S.A. de CV

07/21/2020

Optimus Instant Hand Sanitizer

75416-001-04

FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added to import alert to stop products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020

Liqesa Exportacion or Liq-E-S.A. de CV (Mexico)

Liq-E S.A. de CV

07/08/2020

Optimus Lubricants Instant Hand Sanitizer

75416-005-01

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 to import alert to stop products from entering the U.S. on 7/15/2020

Liqesa Exportacion or Liq-E-S.A. de CV (Mexico)

Liq-E S.A. de CV

7/21/2020

Optimus Instant Hand Sanitizer

75416-002-01

75416-004-01

75416-378-04

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added to import alert to stop products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020

Maquiladora Miniara, SA de CV (Mexico)

Maquiladora Miniara, SA de CV

07/10/2020

Shine and Clean Hand Sanitizer

76753-001-01

76753-001-02

76753-001-03

FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily recalled on 7/9/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

Maquiladora Miniara SA de CV (Mexico)

Bodega Latina Corp.

07/10/2020

Selecto Hand Sanitizer

76753-002-01

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

MXL Comercial SA de CV (Mexico)

Resource Recovery and Trading LLC

07/15/2020

Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol

77106-002-01

FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020

MXL Comercial SA de CV (Mexico)

Resource Recovery and Trading LLC

07/15/2020

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

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020

Mystic International SA de CV (Mexico)

Transliquid Technologies LLC

07/02/2020

Mystic Shield Protection hand sanitizer

75477-435-02

75477-435-10

75477-435-12

75477-435-25

75477-435-50

75477-534-10

Company tested product; contains methanol; product voluntarily recalled by Transliquid Technologies LLC on 7/2/2020

Notarika SA de CV (Mexico)

Notarika SA de CV

8/03/2020

Greenfrog Hand Sanitizer

77031-454-05

77031-454-34

77145-000-01

77145-000-02

FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added to import alert to stop products from entering the U.S. on 8/11/2020

Notarika SA de CV (Mexico)

Notarika SA de CV

08/03/2020

Greenfrog Hand Sanitizing wipes

77145-001-00

77145-001-01

77145-001-02

77145-001-03

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 to import alert to stop products from entering the U.S. on 8/11/2020

Noticias Mexico Hoy Grupo Multimedia (Mexico)

Medical Mary LLC

08/06/2020

Medical Mary Clean Hand Sanitizer

76839-521-01

76839-521-04

76839-522-03

 

FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product

Noticias Mexico Hoy Grupo Multimedia (Mexico)

AMX Premium Cleaning Services LP

08/06/2020

AMX Instant Hand Sanitizer

76839-523-05

FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls

Open Book Extracts

Open Book Extracts

 

08/11/2020

Always Be Clean Hand Sanitizer

75091-2020-1

75091-2020-2

75091-2020-3

Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020

Open Book Extracts

Just Hand Sanitizer

08/11/2020

Just Hand Sanitizer Single Use Packs

78065-2020-1

78065-2020-2

Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020

Plastico Las Palmas SA de CV

Comercial Goura S de RL and S&L Brands

08/11/2020

BV BYE Virus 99

 

 

76560-0001-2

76560-0001-3

76560-0001-4

76560-0001-5

76560-0001-6

76560-0001-8

FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added to import alert to stop products from entering the U.S. on 8/6/2020

Plastico Las Palmas SA de CV

Admay Consulting LLC

08/11/2020

In Good Hands Hand Sanitizer Gel

76560-0002-1

76560-0002-2

76560-0002-3

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 to import alert to stop products from entering the U.S. on 8/6/2020

Precision Analitica Integral SA de CV

ESPMEX LLC

08/07/2020

CleanCare Nogerm Advanced Hand Sanitizer

77492-006-25

77492-007-01

77492-008-50

77492-009-05

FDA tested product; contains methanol; ethanol alcohol level was subpotent; FDA recommended the company recall on 8/6/2020

Quimica Magna de Mexico SA de CV (Mexico)

 

08/03/2020

Datsen Hand Sanitizer

Not Listed

FDA tested product; ethanol alcohol level was subpotent; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020

Quimica Magna de Mexico SA de CV (Mexico)

Quimica Magna de Mexico SA de CV

08/03/2020

Alcohol Antiseptic 62% Hand Sanitizer

74844-162-02

74844-162-08

74844-162-17

74844-162-34

FDA tested product; ethanol alcohol level was subpotent; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020

Quimica Magna de Mexico SA de CV (Mexico)

Inflatables LLC

08/03/2020

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

Product purported to be made at the same facility that produced subpotent product; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020

Quimica Magna de Mexico SA de CV (Mexico)

Inflatables LLC

08/03/2020

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

Product purported to be made at the same facility that produced subpotent product; added to import alert to stop products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020

Real Clean Distribuciones SA de CV (Mexico)

Scent Theory Products LLC

07/14/2020

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

FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020

Real Clean Distribuciones SA de CV (Mexico)

Scent Theory Products LLC

07/14/2020

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

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

Real Clean Distribuciones SA de CV (Mexico)

Scent Theory Products LLC

07/14/2020

Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer

76891-102-11

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020

Real Clean Distribuciones SA de CV (Mexico)

Cavalry Sanitizers LLC

07/14/2020

Cavalry (labeled with “Product of Mexico”)

75460-070-01

75460-070-02

75460-070-05

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

Real Clean Distribuciones SA de CV (Mexico)

Procurement Services LLC

07/14/2020

ENLIVEN Hand Sanitizing Gel

74882-341-01

74882-341-02

74882-341-03

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020

Real Clean Distribuciones SA de CV (Mexico)

Procurement Services LLC

07/14/2020

Lux Eoi Hand Sanitizing Gel

74882-007-01

74882-007-02

74882-007-03

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020

Real Clean Distribuciones SA de CV (Mexico)

Scent Theory Products Inc.

07/14/2020

Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer

73389-102-11

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added to import alert to stop products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/23/2020

Roque Plast SA de CV (Mexico)

Roque Plast SA de CV

08/03/2020

Command Gel AntiBac Instant hand sanitizer

50058-100-08

FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily recalled 8/4/2020

Santa Cruz Biotechnology

Santa Cruz Biotechnology

8/11/2020

UltraCruz Hand Sanitizing Gel Antimicrobial

90032-214-08

90032-214-83

90032-214-94

Company tested product; ethanol alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020

SG24 LLC

 

8/11/2020

SkinGuard24 All-Day Hand Sanitizer

Not listed

Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020

Spartan Chemical Co Inc. (Ohio)

 

08/03/2020

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

Spartan Chemical Co Inc. (Ohio)

 

08/03/2020

foamyiQ Lemon Blossom Hand Sanitizer

64009-202-06

Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020

Soluciones Cosmeticas SA de CV (Mexico)

Private D Capital Group Corp., Human Choice LLC and

RediBag USA

Astrum LLC

07/02/2020

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

FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added to import alert to stop 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

Soluciones Cosmeticas SA de CV (Mexico)

Astrum LLC

07/02/2020

Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer

75165-600-01

FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020

Soluciones Cosmeticas SA de CV (Mexico)

Human Choice LLC

07/02/2020

Purity Advanced Hand Sanitizer

75165-008-01

Product purported to be made at the same facility that produced methanol contaminated product FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020

Soluciones Cosmeticas SA de CV (Mexico)

Wet Look Janitorial and Gardening Corp.

07/10/2020

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

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020

Tritanium Labs USA LLC

Tritanium Labs LLC

07/30/2020

TriCleanz Tritanium Labs Hand Sanitizer

(Labeled with “Made in Mexico”)

77757-111-01

Product purported to be made at the same facility as Incredible Products SA de CV that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020

Tropicosmeticos SA de CV (Mexico)

Soflo Urban Team LLC

07/02/2020

Britz Hand Sanitizer Ethyl Alcohol 70%

 

 

76676-402-01

76676-402-02

76676-402-14

 

 

 

 

FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

Soflo Urban Team LLC

07/02/2020

Parabola Hand Sanitizer

 

76676-402-03

76676-402-09

 

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

Liberty International Distributors

07/02/2020

Urbane Bath and Body Hand Sanitizer

 

 

76676-402-04

 

 

 

 

 

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

Liberty International Distributors

07/02/2020

Cleaner Hand Sanitizer Rinse Free 70%

 

 

76676-402-07

76676-402-08

 

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

Liberty International Distributors

07/02/2020

Handzer Hand Sanitizer Rinse Free

76676-402-10

76676-402-11

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

Up in the Lab

07/02/2020

Kleanz Antibacterial Hand Sanitizer Advanced

76676-402-05

76676-402-06

76676-402-12

76676-402-13

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

BeSafe Industries LLC

07/02/2020

Be Safe Hand Sanitizer

76676-402-16

76676-402-17

76676-402-18

76676-402-19

 

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Tropicosmeticos SA de CV (Mexico)

C&A Marketing Inc.

07/02/2020

Wave Hand Sanitizer Gel

76676-402-20

Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added to import alert to stop products from entering the U.S. on 7/10/2020

Volu-Sol, Inc.

(Utah)

Volu-Sol

08/11/2020

Volu-Sol Handrub Sanitizing Solution

74401-800-16

74401-800-32

Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020

Yara Elena De La Garza Perez Nieto (Mexico)

 

Yara Elena De La Garza Perez Nieto

07/10/2020

DAESI Hand Sanitizer

 

77268-001-01

FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added to import alert to stop products from entering the U.S. on 7/17/2020

Yangzhou Olande Cosmetic Co. Ltd

(China)

Corgiomed Inc.

08/11/2020

Leafree Instant Hand Sanitizer

76573-160-18

76573-170-19

76573-370-05

76573-390-16

76573-530-09

76573-550-09

76573-820-10

76573-821-11

76573-822-12

Product labeled to be “edible alcohol”; added to import alert to stop products from entering the U.S. on 8/11/2020

*public notification first occurred through FDA statement posted on 06/19/2020

Back to Top