FDA Recll: Hand Sanitizer

1. 4E Global's Blumen Clear Advanced Hand Sanitizer (70 percent alcohol)

2. 4E Global's Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol (70 percent alcohol)

3. 4E Global's Blumen Advanced Instant Hand Sanitizer Clear

4. 4E Global's KLAR Instant Hand Sanitizer labeled as Greenbrier International Inc.

5. 4E Global's DANVER Instant Hand Sanitizer labeled as Greenbrier International Inc.

6. 4E Global's Modesa Instant Hand Sanitizer Moisturizers and Vitamin E

7. 4E Global's Blumen Advanced Hand Sanitizer

8. 4E Global's Blumen Advanced Hand Sanitizer Aloe

9. 4E Global's Blumen Advanced Instant Hand Sanitizer Lavender

10. 4E Global's Blumen Clear Lear Advanced Hand Sanitizer

11. 4E Global's Blumen Clear Advanced Hand Sanitizer

12. 4E Global's The Honeykeeper Hand Sanitizer

13. 4E Global's Blumen Advanced Hand Sanitizer Clear

14. 4E Global's Blumen Clear Advanced Instant Hand Sanitizer

15. 4E Global's Blumen Clear Advanced Instant Hand Sanitizer Aloe

16. 4E Global's Blumen Clear Advanced Instant Hand Sanitizer Lavender

17. 4E Global's Blumen Aloe Advanced Hand Sanitizer, with 70 percent alcohol

18. 4E Global's Blumen Advanced Hand Sanitizer Lavender, with 70 percent alcohol

19. 4E Global's Blumen Advanced Hand Sanitizer Aloe, with 70 percent alcohol

20. 4E Global's Blumen Antibacterial Fresh Citrus Hand Sanitizer

21. 4E Global's Blumen Hand Sanitizer Fresh Citrus

22. 4E Global's Klar Instant Hand Sanitizer

23. 4E Global's Danver Instant Hand Sanitizer

24. 4E Global's Hello Kitty by Sanrio Hand Sanitizer

25. 4E Global's Assured Instant Hand Sanitizer (Vitamin E and Aloe)

26. 4E Global's Assured Instant Hand Sanitizer (Aloe and Moisturizers)

27. 4E Global's Assured Instant Hand Sanitizer Vitamin E and Aloe

28. 4E Global's Assured Instant Hand Sanitizer Aloe and Moisturizers

29. 4E Global's Blumen Instant Hand Sanitizer Fragrance-Free

30. 4E Global's Blumen Instant Hand Sanitizer Aloe Vera

31. 4E Global's Assured Aloe

32. AAA Cosmetica's bio aaa Advance Hand Sanitizer

33. AAA Cosmetica's LumiSkin Advance Hand Sanitizer (multiple sizes)

34. AAA Cosmetica's QualitaMed Hand Sanitizer

35. DDI Multinacional's Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced

36. DDI Multinacional's Hand Sanitizer Agavespa Skincare

37. DDI Multinacional's Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare

38. Eskbiochem's All-Clean Hand Sanitizer

39. Eskbiochem's Esk Biochem Hand Sanitizer

40. Eskbiochem's Lavar 70 Gel Hand Sanitizer

41. Eskbiochem's The Good Gel Antibacterial Gel Hand Sanitizer

42. Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer, with 80 percent alcohol

43. Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer, with 75 percent alcohol

44. Eskbiochem's Saniderm Advanced Hand Sanitizer

45. Grupo Insoma's Hand sanitizer Gel Unscented, with 70 percent alcohol

46. Limpo Quimicos' Andy's Best

47. Limpo Quimicos' Andy's

48. Limpo Quimicos' Gelclor

49. Limpo Quimicos' NeoNatural

50. Limpo Quimicos' Plus Advanced

51. Liqesa Exportacion (Liq-E-S.A.) Optimus Lubricants Instant Hand Sanitizer

52. Maquiladora Miniara's Shine and Clean Hand Sanitizer

53. Maquiladora Miniara's Selecto Hand Sanitizer

54. Mystic International's Mystic Shield Protection Hand Sanitizer

55. Soluciones Cosmeticas' Bersih Hand Sanitizer Gel Fragrance-Free

56. Soluciones Cosmeticas' Antiseptic (alcohol 70 percent) Topical Solution hand sanitizer

57. Soluciones Cosmeticas' Hand Sanitizer labeled as Wet Look Janitorial

58. Soluciones Cosmeticas' Hand Sanitizer labeled as Gardening Corp.

59. Tropicosmeticos' Britz Hand Sanitizer (ethyl alcohol 70 percent)

60. Yara Elena De La Garza Perez Nieto's DAESI hand sanitizer

61. Real Clean Distribuciones's Born Basic Anti-Bac Hand Sanitizer

62. Real Clean Distribuciones's Anti-Bac Hand Sanitizer

63. Real Clean Distribuciones's Scent Theory Pure Clean Anti-bacterial Hand Sanitizer

64. Real Clean Distribuciones's Cavalry

65. Real Clean Distribuciones's Enliven Hand Sanitizing Gel

66. Real Clean Distribuciones's Lux Eoi Hand Sanitizing Gel

67. Real Clean Distribuciones's Keep It Clean

68. Real Clean Distribuciones's Hand Sanitizer

69. MXL Comercial's Hand Sanitizer Disinfectant Gel, with 70 percent ethyl alcohol

70. MXL Comercial's Hand Sanitizer Disinfectant Gel (70 percent ethyl alcohol) Rinse Free Hand Rub

71. Liqesa Exportacion Optimus Lubricants Instant Hand Sanitizer

72. Scent Theory 'Keep It Clean' Anti-Bacterial Hand Sanitizer

73. MXL Comercial / Resource Recovery & Trading Hand Sanitizer Disinfectant Gel (70 percent ethyl alcohol

74. Eskbiochem 361 All Clean Hand Sanitizer, Moisturizer and Disinfectant

75. Saniderm Advanced Hand Sanitizer (officially banned from imports on July 15)

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products | FDA

Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death

The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products—and improper manufacturing practices.

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June. The agency issued a further warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported to poison control centers and state departments of health. The agency continues to see these figures rise.

“Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”

The agency has posted a do-not-use list of dangerous hand sanitizer products, which is being updated regularly. In most cases, methanol does not appear on the product label. However, methanol is not an acceptable ingredient in any drug, including hand sanitizer, even if methanol is listed as an ingredient on the product label. The FDA’s ongoing testing has found methanol contamination in hand sanitizer products ranging from 1% to 80%.

Importantly, the FDA is urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products. Manufacturers’ failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning. One of the reported deaths is associated with Blumen Hand Sanitizer, distributed by 4e North America and manufactured by 4E Global in Mexico, who recently expanded its recall to include additional lots of its hand sanitizer products. Additionally, the FDA is strongly urging distributors and retailers to stop distributing and selling hand sanitizers manufactured by the firms on the list immediately, even if the particular product is not included in a recall, due to the risk of methanol poisoning.

When identifying hand sanitizers from the FDA’s do-not-use list, consumers should look for one or more identifiers from the list that match the product’s labeling, including:

-Manufacturer name

-Product name

-National Drug Code (NDC) number

If any of the identifiers (name, company, or NDC) match a product on the list, the FDA urges consumers to immediately stop using the hand sanitizer. Dispose of the hand sanitizer bottle in a hazardous waste container, if available, or dispose of as recommended by local waste management and recycling centers. Do not flush or pour these products down the drain or mix with other liquids.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.

The 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 to identify the product as possible):

Complete and submit the report online; or

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.