FDA Releases New Warning Against Using Hand Sanitizers Containing Methanol
Posted on July 13, 2020 | in Safety
In a newly released update, the 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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