Hand Sanitizer Recall Designated Class I

A recall for M hand sanitizer from Medek has been designated Class I by the US Food and Drug Administration (FDA), according to the FDA’s August 24, 2022, Enforcement Report.

The most serious of the administration’s recall classifications, Class I warns there is reasonable probability that use of the product will cause serious adverse health consequences or death.

The recall affects all lots of M hand sanitizer alcohol antiseptic 80%, 128 oz/3785 mL (NDC 75432-001-02), which was distributed in Texas in April and May of 2020, according to a Medek company announcement dated September 9, 2020. The recalled hand sanitizer is packaged in a 1-gallon high-density polyethylene plastic bottle.

An FDA analysis found the hand sanitizer contained methanol and was subpotent for ethanol, Medek stated.

“Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death,” the company explained. “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.”

Additionally, subpotent hand sanitizer, through a lack of efficacy, could increase the risk of infections.

Medek voluntarily initiated the recall September 9, 2020. On August 15, 2022, the FDA issued its Class I designation.