• REGULATORY ALERT: FDA Expands Recall List for Toxic Hand Sanitizers

  • REGULATORY ALERT: FDA Expands Recall List for Toxic Hand Sanitizers

    The products contain high levels of wood alcohol that could cause death.


    From NACS

    The U.S. Food and Drug Administration has expanded its list of recalled hand sanitizers to at least 75, saying toxic levels of wood alcohol in those products can cause injury or even death. Some were sold at national chains, such as Walmart and Costco.

    According to NBC News, the FDA has discovered an increase in hand sanitizers that are labeled to contain ethyl alcohol, or ethanol, but in fact test positive for methanol, or wood alcohol. If methanol is absorbed through the skin, it can cause blindness and hospitalizations. If ingested, it can cause death.

    Since the pandemic began, health officials have continuously urged Americans to wash their hands for 20 seconds at a time or to use hand sanitizer to protect against exposure to COVID-19. The demand for hand sanitizer has surged, and questionable new brands have made their way to store shelves in the United States. Most of the brands in question were imported from Mexico.

    “Unfortunately, there are some companies taking advantage of the increased usage of hand sanitizer during the coronavirus pandemic and [are] putting lives at risk by selling products with dangerous and unacceptable ingredients,” said Dr. Stephen Hahn, FDA commissioner. “Consumers and health-care providers should not use methanol-containing hand sanitizers.”

    According to Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest, selling these hand sanitizers is like selling an unapproved drug.

    “When you’re in a company and you’re buying products in bulk, as sanitizer is purchased, you want to understand the provenance of that product—where it was manufactured, whether or not it’s been approved under good manufacturing standards brought by the FDA—and clearly that was simply ignored,” he said.

    BJ’s wholesale club recently recalled Blumen Clear Advanced Hand Sanitizer with 70% alcohol due to its methanol content. “Out of an abundance of caution, 4E Brands requests that members discontinue the use of this product immediately and dispose of it in accordance with local regulations,” the company said in a statement. Costco and Walmart also recalled Blumen hand sanitizer.

    In June, the FDA first warned about nine products made in Mexico, and since then, dozens more have been added to the list. It's unclear how the products are ending up in U.S. stores, but there may be dozens of new hand sanitizer brands created since the beginning of the pandemic.

    Ten deaths and dozens of hospitalizations in Arizona and New Mexico are believed to be linked to methanol in hand sanitizers. The cases are also associated with alcohol use disorder.

    The Centers for Disease Control and Prevention recommends that consumers use alcohol-based hand sanitizers containing at least 60% ethyl alcohol (ethanol), which should be clearly labeled on the container. It's not advised to add alcohol to a non-alcohol hand sanitizer.

    The FDA has issued an import alert on several brands of hand sanitizers to stop the products from entering the U.S., including:

    • Blumen products
    • Klar and Danver Instant Hand Sanitizer (labeled with Greenbrier International)
    • Modesa Instant Hand Sanitizer Moisturizers and Vitamin E
    • Hello Kitty by Sanrio Hand Sanitizer
    • Assured Aloe

    For the complete list, go to FDA hand sanitizer updates.