FDA Recalls Hand Sanitizers

Image submitted.

A federal recall of hand sanitizers has grown to include more than 75 products.

The FDA is warning consumers and health care providers about hand sanitizers which are labeled as containing ethanol—also known as ethyl alcohol—but actually contain methanol. Methanol, or wood alcohol, can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested, according to an FDA press release.

Among the brands being recalled are All Clean, Esk Biochem, Lavar, CleanCare NoGerm, Mystic Shield, Blumen, Andy’s, Andy’s Best, Born Basic and Optimus. Some of the products were sold in bulk while others were sold at retail outlets, such as Blumen, which was sold at Sam’s Club and other stores, and Born Basic, which was sold at Target.

Among the manufacturers impacted by the recall are 4E Global, AAA Cosmetica, Eskbiochem, Grupo Insoma, Mystic International, Real Clean Distribuciones and Soluciones Cosmeticas. All are located in Mexico but have been sold in the United States.

For a full list of the products being recalled and the manufacturers, visit the FDA website.

The FDA said consumers, both adults and children, ingesting hand sanitizer contaminated with methanol has led to blindness, hospitalizations and death.

Symptoms of methanol poisoning include 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 for methanol poisoning, young children who accidentally ingest the products and adolescents and adults who drink hand sanitizers as either an alcohol substitute of to prevent COVID-19 infection are most at risk. Consumers experiencing symptoms should seek immediate treatment, the FDA said.

To prevent coronavirus infection, consumers are asked to wash their hands often with soap and water for at least 20 seconds, especially after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention recommend using an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

According to a press release, the FDA 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.

The FDA said it has received reports of adverse events associated with hand sanitizer products. Health care professionals, consumers and patients are asked to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

This investigation is ongoing. The FDA said it will provide additional information as it becomes available.

Leave a Comment