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Posted July 28, 2022

FDA Warns Three Manufacturers of Sanitizer for Manufacturing and Misbranding Violations

Between July 8 and July 21, the FDA issued warning letters to three companies selling hand sanitizer products that violate Current Good Manufacturing Practices (cGMP), are adulterated and misbranded, and for refusal to allow the agency to access and copy company records. For more information, see the links below:

  • Jose Miguel Gutierrez Salas (MVP Sanitizing SPRAY HAND SANITIZER): The company was warned for substituting the ingredient ethanol with methanol, a poisonous and unapproved ingredient. Substantial exposure to methanol can lead to adverse effects such as vomiting, headache, blurred vision, permanent blindness, coma, permanent damage to the central nervous system, and death.
  • Custom Research Labs Inc. (HAND SANITIZER and BAK-OFF Instant Hand Sanitizer)
  • Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. (Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER)

The FDA first warned consumers about adulterated hand sanitizers in June of 2020 and has continued to update consumers about potentially-affected products.

Each company is required to respond in writing to the FDA within 15 days outlining steps taken to address any violations.

Learn more about hand sanitizers in ConsumerLab’s article about coronavirus and disinfection.

See related recalls and warnings:

FDA Tests Find Imported Hand Sanitizer Contains Less Active Ingredient Than Claimed

Mandalorian and Mickey Mouse Hand Sanitizers Recalled Due to Benzene, Methanol

FDA Warns Sanitizer Corporation For Manufacturing and Misbranding Violations

Hand Sanitizer Sold at Ulta, TJ Maxx, and Marshalls Recalled Due to Toxic Chemicals