July 31, 2020

Audience: Consumer, Health Professional

Update July 31, 2020: FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol.

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 people ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.

Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA maintains a list of FDA-tested and recalled hand sanitizers on the agency’s website, which will be continually updated as dangerous products are discovered. FDA’s investigation of methanol in certain hand sanitizers is ongoing.

Do not use any products on this list of hand sanitizers with potential methanol contamination, and continue checking this list often as it is being updated daily.

The agency will provide additional information as it becomes available.

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 accidentally 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
• 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 list 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.

Health professionals and consumers 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.

Source: FDA