FDA MedWatch - Hand Sanitizers with Methanol

In a rush to manufacture and distribute hand sanitizers some companies took shortcuts and had defective alcohol production methods resulting in the production of methanol.  This was also a problem during the era of prohibition in the 1920s.  Methanol is toxic to the optic nerve and will cause blindness.  

MedWatch Safety Alert was added to the FDA Drug Safety and Availability webpage. 

TOPIC: Hand Sanitizers with Methanol: FDA Updates 

AUDIENCE: Consumer, Health Professional 

ISSUE: 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.

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.

Recent recalls include: 







BACKGROUND: 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, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
RECOMMENDATION:
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.

This 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, or 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.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.










FDA MedWatch - Hand Sanitizers with Methanol