7/2/2020: UPDATE – FDA warns consumers of risk of methanol contamination in certain hand sanitizers

[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 active 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.

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 testing and manufacturer/distributor recalls

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.
  • That is being recalled by the manufacturer or distributor.
  • That 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.

4E Global, SAPI de CV (Mexico)07/08/2020Blumen Clear Advanced Hand Sanitizer with 70% AlcoholNot listedFDA tested product; contains methanol; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%Not listedFDA tested product; contains methanol; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Advanced Instant Hand Sanitizer Clear60599-015-00
60599-015-01
60599-015-02
FDA tested product; contains methanol; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020KLAR AND DANVER Instant Hand Sanitizer (labeled with Greenbrier International Inc.)33992-8010-1Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020MODESA Instant Hand Sanitizer Moisturizers and Vitamin E60599-007-33Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Advanced Hand Sanitizer60599-012-00
60599-012-01
60599-012-02
60599-012-03
60599-012-04
60599-012-05
60599-012-06
60599-012-07
60599-012-08
60599-012-10
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Advanced Hand Sanitizer Aloe60599-013-00
60599-013-01
60599-014-00
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Advanced Instant Hand Sanitizer Lavender60599-016-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Clear LEAR Advanced Hand Sanitizer60599-017-00
60599-017-01
60599-018-00
60599-018-01
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUEMEN Clear Advanced Hand Sanitizer60599-018-02
60599-018-03
60599-018-04
60599-018-05
60599-018-06
60599-018-07
60599-018-08
60599-019-00
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020The Honeykeeper Hand Sanitizer60599-020-00
60599-020-01
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Advanced Hand Sanitizer Clear60599-024-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Clear Advanced Instant Hand Sanitizer60599-025-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Clear Advanced Instant Hand Sanitizer Aloe60599-026-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Clear Advanced Instant Hand Sanitizer Lavender60599-027-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol60599-028-00
60599-029-00
Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol60599-046-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol60599-047-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Blumen Antibacterial Fresh Citrus Hand Sanitizer60599-501-01Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Blumen Hand Sanitizer Fresh Citrus60599-502-01Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020KLAR and DANVER INSTANT HAND SANTIZER60599-801-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Hello Kitty by Sanrio Hand Sanitizer60599-802-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Assured Instant Hand Sanitizer (Vitamin E and Aloe)60599-850-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Assured Instant Hand Sanitizer (Aloe and Moisturizers)60599-851-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Assured Instant Hand Sanitizer Vitamin E and Aloe60599-852-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Assured Instant Hand Sanitizer Aloe and Moisturizers60599-853-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Instant Hand Sanitizer Fragrance Free60599-854-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020BLUMEN Instant Hand Sanitizer Aloe Vera60599-855-00Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico)07/08/2020Assured Aloe60599-999-10Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
AAA Cosmetica (Mexico)07/06/2020bio aaa Advance Hand Sanitizer 76987-402-01FDA tested product; contains methanol; FDA recommended a recall on 07/02/2020; added to import alert to stop products from entering the U.S. on 7/7/2020
AAA Cosmetica (Mexico)07/06/2020LumiSkin Advance Hand Sanitizer 4 oz76987-120-01Product purported to be made at the same facility; FDA recommended a recall on 07/02/2020; added to import alert to stop products from entering the U.S. on 7/7/2020
AAA Cosmetica (Mexico)07/06/2020LumiSkin Advance Hand Sanitizer 16 oz76987-402-02Product purported to be made at the same facility; FDA recommended a recall on 07/02/2020; added to import alert to stop products from entering the U.S. on 7/7/2020
AAA Cosmetica (Mexico)07/06/2020QualitaMed Hand Sanitizer  76987-250-01Product purported to be made at the same facility; FDA recommended a recall on 07/02/2020; added to import alert to stop products from entering the U.S. on 7/7/2020
DDI Multinacional SA de CV (Mexico)07/08/2020Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced74949-002-20
74949-002-25
74949-002-49
74949-002-60
FDA tested product; contains methanol; product retained at the border; FDA recommended a recall on all other potential products on the market on 6/29/2020
DDI Multinacional SA de CV (Mexico)07/08/2020Hand Sanitizer Agavespa Skincare77415-000-00Product purported to be made at the same facility; FDA recommended a recall on other all potential products on the market on 6/29/2020
DDI Multinacional SA de CV (Mexico)07/08/2020Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare77056-000-01Product purported to be made at the same facility; FDA recommended a recall on all other potential products on the market on 6/29/2020
Eskbiochem SA de CV (Mexico)*07/02/2020All-Clean Hand Sanitizer74589-002-01Product purported to be made at the same facility; product voluntarily recalled by ITECH 361
Eskbiochem SA de CV (Mexico)*07/02/2020Esk Biochem Hand Sanitizer74589-007-01Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico)*07/02/2020Lavar 70 Gel Hand Sanitizer74589-006-01FDA tested product; contains methanol
Eskbiochem SA de CV (Mexico)*07/02/2020The Good Gel Antibacterial Gel Hand Sanitizer74589-010-10Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico)*07/02/2020CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol74589-005-03Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico)*07/02/2020CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol74589-009-01FDA tested product; contains methanol
Eskbiochem SA de CV (Mexico)*07/02/2020CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol74589-003-01Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico)*07/02/2020Saniderm Advanced Hand Sanitizer74589-001-01Product purported to be made at the same facility; product recalled by Saniderm Products and UVT Inc.
Grupo Insoma, S.A.P.I de CV (Mexico)07/02/2020Hand sanitizer Gel Unscented 70% Alcohol75744-0200-3
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 a recall on 07/01/2020
Limpo Quimicos SA de CV
(Mexico)
07/08/2020Andy’s Best73755-120-01
73755-120-02
73755-120-04
FDA tested product; contains methanol; FDA recommended a recall on 07/08/2020
Limpo Quimicos SA de CV
(Mexico)
07/08/2020Andy’s73755-110-01
73755-130-02
Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Limpo Quimicos SA de CV
(Mexico)
07/08/2020Gelclor73755-140-01Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Limpo Quimicos SA de CV
(Mexico)
07/08/2020NeoNatural73755-200-01
73755-200-02
Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Limpo Quimicos SA de CV
(Mexico)
07/08/2020Plus Advanced73755-300-01Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Liqesa Exportacion or Liq-E-S.A. de CV (Mexico)07/08/2020Optimus Lubricants Instant Hand Sanitizer75416-004-01
75416-005-01
FDA tested product; contains methanol; FDA recommended a recall on 07/07/2020; company is not registered with FDA; additional products may be on the market
Maquiladora Miniara, SA de CV (Mexico)07/10/2020Shine and Clean Hand Sanitizer76753-001-01
76753-001-02
76753-001-03
FDA tested product; contains methanol; FDA recommended a recall on 07/09/2020
Maquiladora Miniara, SA de CV (Mexico)07/10/2020Selecto Hand Sanitizer76753-002-01Product purported to be made at the same facility; FDA recommended a recall on 07/10/2020
Mystic International SA de CV (Mexico)07/02/2020Mystic Shield Protection hand sanitizer75477-435-02
75477-435-10
75477-435-12
75477-435-25
75477-435-50
75477-534-10
Contains methanol; product voluntarily recalled by Transliquid Technologies LLC
Soluciones Cosmeticas SA de CV (Mexico)07/02/2020Bersih Hand Sanitizer Gel Fragrance Free75165-000-01
75165-001-01
75165-003-02
75165-004-01
75165-005-01
75165-006-01
75165-008-01
75165-250-01
75165-600-01
FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020
Soluciones Cosmeticas SA de CV (Mexico)07/02/2020Antiseptic Alcohol 70% Topical Solution hand sanitizerNot listedFDA tested product; contains methanol; FDA recommended a recall on 07/01/2020
Soluciones Cosmeticas SA de CV (Mexico)07/10/2020Hand sanitizer (labeled with Wet Look Janitorial and Gardening Corp.)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; FDA recommended a recall on 07/01/2020
Tropicosmeticos SA de CV (Mexico)07/02/2020Britz Hand Sanitizer Ethyl Alcohol 70%76676-402-01
77676-402-02
77676-402-03
77676-402-04
77676-402-05
77676-402-06
77676-402-07
77676-402-08
77676-402-09
77676-402-10
77676-402-11
77676-402-12
77676-402-13
77676-402-14
77676-402-16
77676-402-17
77676-402-18
77676-402-19
77676-402-20
FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020
Yara Elena De La Garza Perez Nieto07/10/2020DAESI hand sanitizer77268-001-01FDA tested product; contains methanol; FDA recommended a recall on 07/10/2020

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