[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) | 07/08/2020 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Lavar 70 Gel Hand Sanitizer | 74589-006-01 | FDA tested product; contains methanol |
| 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 75% Alcohol | 74589-009-01 | FDA tested product; contains methanol |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
FILED UNDER: Home Healthcare
