FDA Releases New Warning Against Using Hand Sanitizers Containing Methanol

In a newly released updatethe Food and Drug Administration (FDA) has expanded the number of hand sanitizers to avoid using to include those that may contain methanol (also called methyl alcohol or wood alcohol)which can be a toxic substance when absorbed through skin or ingested.  

The agency provided a chart of 59 varieties of hand sanitizer that should be avoided, some which have already been recalled, and other products being recommended for recalls as they may contain the potentially fatal ingredient. It states that while these varieties are labeled to contain ethanol (also known as ethyl alcohol), they have tested positive for methanol contamination.  

Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. The FDA says its investigation of methanol in certain hand sanitizers is ongoing, and will provide additional information as it becomes available. 

The update also stated that those 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 even death.  

The FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers, and 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, the FDA urges individuals 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 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 fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by the 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.  

A list of hand sanitizers in the FDA update to avoid: 

Company Date added to table Product(s) NDC(s) Product status
Mystic International SA de CV (Mexico) 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 Contains methanol; product voluntarily recalled by Transliquid Technologies LLC
Eskbiochem SA de CV (Mexico) *07/02/2020 Lavar 70 Gel Hand Sanitizer 74589-006-01 FDA tested product; contains methanol
Eskbiochem SA de CV (Mexico) *07/02/2020 CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol 74589-009-01 FDA tested product; contains methanol
Soluciones Cosmeticas SA de CV (Mexico) 07/02/2020 Antiseptic Alcohol 70% Topical Solution hand sanitizer Not listed FDA tested product; contains methanol; FDA recommended a recall on 07/01/2020
AAA Cosmetica (Mexico) 07/06/2020 bio aaa Advance Hand Sanitizer 76987-402-01 FDA 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
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 a recall on 07/06/2020
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 a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Advanced Instant Hand Sanitizer Clear 60599-015-00; 60599-015-01; 60599-015-02 FDA tested product; contains methanol; FDA recommended a recall on 07/06/2020
Liqesa Exportacion or Liq-E-S.A. de CV (Mexico) 07/08/2020 Optimus Lubricants Instant Hand Sanitizer 75416-004-01; 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
Limpo Quimicos SA de CV (Mexico) 07/08/2020 Andy’s Best 73755-120-01; 73755-120-02; 73755-120-04 FDA tested product; contains methanol; FDA recommended a recall on 07/08/2020
Maquiladora Miniara, SA de CV (Mexico) 07/10/2020 Shine and Clean Hand Sanitizer 76753-001-01; 76753-001-02; 76753-001-03 FDA tested product; contains methanol; FDA recommended a recall on 07/09/2020
Yara Elena De La Garza Perez Nieto 07/10/2020 DAESI hand sanitizer 77268-001-01 FDA tested product; contains methanol; FDA recommended a recall on 07/10/2020
DDI Multinacional SA de CV (Mexico) 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 a recall on all other potential products on the market on 6/29/2020
Grupo Insoma, S.A.P.I de CV (Mexico) 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 a recall on 07/01/2020
Soluciones Cosmeticas SA de CV (Mexico) 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; 75165-008-01; 75165-250-01; 75165-600-01 FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020
Tropicosmeticos SA de CV (Mexico) 07/02/2020 Britz 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
Eskbiochem SA de CV (Mexico) *07/02/2020 Esk Biochem Hand Sanitizer 74589-007-01 Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico) *07/02/2020 The Good Gel Antibacterial Gel Hand Sanitizer 74589-010-10 Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico) *07/02/2020 CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol 74589-005-03 Product purported to be made at the same facility
Eskbiochem SA de CV (Mexico) *07/02/2020 CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol 74589-003-01 Product purported to be made at the same facility
Soluciones Cosmeticas SA de CV (Mexico) 07/10/2020 Hand 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
AAA Cosmetica (Mexico) 07/06/2020 LumiSkin Advance Hand Sanitizer 4 oz 76987-120-01 Product 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) 07/06/2020 LumiSkin Advance Hand Sanitizer 16 oz 76987-402-02 Product 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) 07/06/2020 QualitaMed Hand Sanitizer 76987-250-01 Product 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
4E Global, SAPI de CV (Mexico) 07/08/2020 KLAR AND DANVER Instant Hand Sanitizer (labeled with Greenbrier International Inc.) 33992-8010-1 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 MODESA Instant Hand Sanitizer Moisturizers and Vitamin E 60599-007-33 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Advanced Hand Sanitizer 60599-012-00; 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) 07/08/2020 BLUMEN Advanced Hand Sanitizer Aloe 60599-013-00; 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) 07/08/2020 BLUMEN Advanced Instant Hand Sanitizer Lavender 60599-016-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Clear LEAR Advanced Hand Sanitizer 60599-017-00; 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) 07/08/2020 BLUEMEN Clear Advanced Hand Sanitizer 60599-018-02; 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) 07/08/2020 The Honeykeeper Hand Sanitizer 60599-020-00; 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) 07/08/2020 BLUMEN Advanced Hand Sanitizer Clear 60599-024-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Clear Advanced Instant Hand Sanitizer 60599-025-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Clear Advanced Instant Hand Sanitizer Aloe 60599-026-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Clear Advanced Instant Hand Sanitizer Lavender 60599-027-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol 60599-028-00; 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) 07/08/2020 Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol 60599-046-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol 60599-047-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Blumen Antibacterial Fresh Citrus Hand Sanitizer 60599-501-01 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Blumen Hand Sanitizer Fresh Citrus 60599-502-01 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 KLAR and DANVER INSTANT HAND SANTIZER 60599-801-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Hello Kitty by Sanrio Hand Sanitizer 60599-802-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Assured Instant Hand Sanitizer (Vitamin E and Aloe) 60599-850-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Assured Instant Hand Sanitizer (Aloe and Moisturizers) 60599-851-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Assured Instant Hand Sanitizer Vitamin E and Aloe 60599-852-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Assured Instant Hand Sanitizer Aloe and Moisturizers 60599-853-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Instant Hand Sanitizer Fragrance Free 60599-854-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 BLUMEN Instant Hand Sanitizer Aloe Vera 60599-855-00 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
4E Global, SAPI de CV (Mexico) 07/08/2020 Assured Aloe 60599-999-10 Product purported to be made at the same facility; FDA recommended a recall on 07/06/2020
Limpo Quimicos SA de CV (Mexico) 07/08/2020 Andy’s 73755-110-01; 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) 07/08/2020 Gelclor 73755-140-01 Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Limpo Quimicos SA de CV (Mexico) 07/08/2020 NeoNatural 73755-200-01; 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) 07/08/2020 Plus Advanced 73755-300-01 Product purported to be made at the same facility; FDA recommended a recall on 07/08/2020
Maquiladora Miniara, SA de CV (Mexico) 07/10/2020 Selecto Hand Sanitizer 76753-002-01 Product purported to be made at the same facility; FDA recommended a recall on 07/10/2020
DDI Multinacional SA de CV (Mexico) 07/08/2020 Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare 77056-000-01 Product purported to be made at the same facility; FDA recommended a recall on all other potential products on the market on 6/29/2020
DDI Multinacional SA de CV (Mexico) 07/08/2020 Hand Sanitizer Agavespa Skincare 77415-000-00 Product purported to be made at the same facility; FDA recommended a recall on other all potential products on the market on 6/29/2020
Eskbiochem SA de CV (Mexico) *07/02/2020 Saniderm Advanced Hand Sanitizer 74589-001-01 Product purported to be made at the same facility; product recalled by Saniderm Products and UVT Inc.
Eskbiochem SA de CV (Mexico) *07/02/2020 All-Clean Hand Sanitizer 74589-002-01 Product purported to be made at the same facility; product voluntarily recalled by ITECH 361

*public notification first occurred through CDER Alert posted on 06/19/2020 

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