Bayer Announces Voluntary Recall of OTC Antifungal Products

Bayer is recalling its Lotrimin AF and Tinactin spray products due to the presence of the carcinogen benzene.

Bayer announced that it is voluntarily recalling all unexpired Lotrimin AF and Tinactin spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products, according to the press release on the FDA website.

Benzene is not an ingredient in any of Bayer Consumer Health products, the company clarified, and is classified as a human carcinogen, according to the FDA. Exposure to this carcinogen can happen through inhalation, orally, and through the skin. Also, depending on the extent and level of exposure, benzene exposure could lead to an increased risk of blood cancers such as leukemia, blood cancer of the bone marrow, and other blood disorders.

The decision to recall these products is a precautionary and voluntary measure, it was noted, and the levels detected are not expected to cause adverse health consequences in consumers.

Bayer has no known reports of adverse events (AEs) related to this recall as of now.

The affected Lotrimin and Tinactin spray products are over-the-counter antifungal products, sold individually or in combo packs. The impacted products are1:

  • Lotrimin Anti-Fungal (AF) Athlete's Foot Powder Spray
  • Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
  • Lotrimin Anti-Fungal (AF) 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 (JI) Powder Spray
  • Tinactin Athlete’s Foot Deodorant Powder Spray
  • Tinactin Athlete’s Foot Powder Spray
  • Tinactin Athlete’s Foot Liquid Spray

Product images and information on the lot numbers recalled are available at: https://livewell.bayer.com/document/2011.

There are no issues of concern with Lotrimin/Tinactin creams, including Lotrimin Ultra, or any other Bayer products, the company stated.

The recalled products are all packaged in aerosol spray cans and were distributed in the US, Puerto Rico, Canada, and Mexico. The company is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products.

Please see the press release for more information on how to obtain a refund and how to report any AEs or quality issues to the FDA.

This recall is being conducted with the knowledge of the FDA.

Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University and member of Dermatology Times®’ editorial advisory board explained how this is a sign that the benzene concerns are beyond only sunscreen products.

“Bayer’s voluntary recall of aerosol-based [Lotrimin] and Tinactin products signifies that concerns about the supply chain and manufacturing contamination of consumer products with benzene extends beyond sunscreens and after-sun products,” Bunick said. 

“I commend Bayer for recalling products containing a well-known carcinogen, but the larger questions that must be addressed are how specifically the contamination is happening, how to fix it, and how widespread in consumer products the benzene contamination goes.”

Reference:

1. Bayer issues voluntary recall of specific Lotrimin and Tinactin spray products due to the presence of benzene. U.S. Food and Drug Administration. Press release. Published October 1, 2021. Accessed October 12, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene