FDA issues countrywide import alert on Mexican hand sanitizers

Feb. 1, 2021

Warning that hand sanitizer imported from Mexico could be tainted with dangerous chemicals, the U.S. FDA has issued its first-ever countrywide import alert for any category of drug product.

When supplies of hand sanitizer fell short at the start of the pandemic, the FDA responded by issuing temporary, more flexible guidance to help manufacturers meet demands.

Unfortunately, over the course of the ongoing pandemic, the agency says it has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination — a substance that can be toxic when absorbed through the skin and life-threatening when ingested.

The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels.

Under the import alert, all alcohol-based hand sanitizers from Mexico are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. The alert follows a June 2020 FDA Advisory Notice to avoid certain hand sanitizer products manufactured in Mexico

FDA has recently issued new guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.

Read the FDA press release