July 13, 2020: FDA Update - Hand Sanitizers Containing Methanol

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.

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, CDC recommends the use of 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 act 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 maintains a list of testing and manufacturer/distributor recalls and advises consumers not to use hand sanitizers from the companies listed. The list which can be found by clicking this link FDA Updates on Hand Sanitizers with Methanol is based on the information on hand sanitizer labels for consumers to use to identify a product.  Criteria for inclusion include:

• Products that have been tested by FDA and found to contain methanol.
• Products being recalled by the manufacturer or distributor.
• Products purportedly made at the same facility as products that have been tested by FDA and found to contain methanol.

(Source: FDA, 7-2-2020)