Class I, II Recalls for OTC Antifungal Sprays

The presence of benzene in product samples has prompted Bayer to voluntary recall all unexpired Lotrimin Anti-Fungal (AF) and Tinactin spray products with lot numbers beginning with TN, CV, or NAA.

“Benzene is classified as a human carcinogen,” the company explained in an October 1, 2021, statement announcing the recall. “Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening.”

The recall affects the following Lotrimin and Tinactin over-the-counter antifungal spray products, which are sold individually or in combo packs:

• Lotrimin Anti-Fungal Athlete’s Foot Powder Spray,
• Lotrimin Anti-Fungal Jock Itch Athlete’s Foot Powder Spray,
• Lotrimin Anti-Fungal Athlete’s Foot Deodorant Powder Spray,
• Lotrimin AF Athlete’s Foot Liquid Spray,
• Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray,
• Tinactin Jock Itch Powder Spray,
• Tinactin Athlete’s Foot Deodorant Powder Spray,
• Tinactin Athlete’s Foot Powder Spray, and
• Tinactin Athlete’s Foot Liquid Spray,

The recalled products are packaged in aerosol spray cans and were distributed through a variety of retail channels in the United States, Puerto Rico, Canada, and Mexico between September 2018 and September 2021. Lotrimin and Tinactin creams, including Lotrimin Ultra, are not included in the recall.

According to the November 24, 2021, US Food and Drug Administration (FDA) Enforcement Report, all of the recalls were designated Class I or Class II, depending on whether the lots had samples contaminated with benzene or whether they were manufactured at the same facility with the contaminated lots. A Class I designation suggests use of the affected product could cause serious adverse health consequences or death, while a Class II designation advises that use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

The FDA issued the recall classifications November 18, 2021.

References:

Bayer issues voluntary recall of specific Lotrimin and Tinactin spray products due to the presence of benzene. News release. Bayer US LLC; October 1, 2021. Accessed November 24, 2021.

US Food and Drug Administration. Enforcement Report – Week of November 24, 2021. Accessed November 24, 2021. https://www.accessdata.fda.gov/scripts/ires/index.cfm