Lotrimin, Tinactin Recall Sparks Class Action Lawsuit Over Alleged Benzene Contamination

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A proposed class action claims certain Lotrimin and Tinactin anti-fungal sprays have been contaminated with “dangerously high” levels of benzene, a known human carcinogen.

The 32-page case was filed in the wake of an October 2021 recall of the allegedly contaminated products. The lawsuit contends the recall did not go far enough to compensate consumers and ensure defendant Bayer U.S.’s products will be protected from future contamination.

According to the suit, the presence of benzene—a component of crude oil, gasoline and cigarette smoke that has been linked to leukemia and other cancers—in the affected Lotrimin and Tinactin sprays renders the products adulterated and misbranded, meaning they are illegal to sell under federal law.

The case claims consumers who have purchased the allegedly contaminated anti-fungal sprays have suffered financial injury in that they purchased “worthless” products and were never warned that the medications contained “harmful levels” of benzene.

“In sum,” the complaint reads, “Plaintiffs seek to recover damages because the Products are adulterated, defective, worthless, and unfit for human use due to the presence of benzene, a carcinogenic and toxic chemical impurity.”

Central to the lawsuit is an October 1 recall issued by Bayer U.S. over the presence of benzene in samples of the company’s anti-fungal sprays. The recall covered “all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021,” and identified specifically the following products:

• 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

The suit argues that Bayer’s assertion that benzene is “not an ingredient” in any Bayer Consumer Health products indicates that its presence in the Lotrimin and Tinactin products was the result of contamination. The lawsuit alleges that had Bayer followed federal good manufacturing practices (GMP) and properly tested its products, the benzene contamination would have been discovered “almost immediately.”

“Accordingly, Defendant knowingly, or at least negligently, introduced contaminated, adulterated, and/or misbranded antifungal medications containing dangerous amounts of benzene into the U.S. market,” the complaint contests.

The lawsuit says the presence of benzene in Lotrimin and Tinactin products is especially concerning given the harmful substance can be absorbed through the skin. Per the case, Lotrimin is the brand name for Clotrimazole, an anti-fungal medication used to treat vaginal yeast infections, oral thrush, diaper rash, pityriasis versicolor, and types of ringworm, including athlete’s foot and jock itch. Tinactin, the suit explains, is the brand name for Tolnaftate, another anti-fungal medication found to be less effective than Clotrimazole for treating athlete’s foot but effective at treating ringworm passed from pets to humans.

The lawsuit argues that although Bayer has claimed as part of the recall that consumers who submit proof of purchase can obtain a refund, the recall is nevertheless “inadequate” for multiple reasons. According to the case, the defendant failed to adequately publicize the recall and the refund offer such that many consumers were unaware that they could request a refund. Moreover, consumers are required to submit a picture of the affected product as proof of purchase, the case says, arguing that because the products are disposable over-the-counter medications, many consumers are unlikely to have held on to their empty bottles, especially for products from as far back as September 2018.

The suit goes on to claim that the recall moreover does not promise any change to Bayer’s manufacturing or distribution process, meaning protection from future contamination is not guaranteed. Additionally, consumers in states such as New York, where consumer protection laws entitle buyers to statutory damages beyond that of the purchase price, will not be adequately compensated under the recall, the case attests.

Finally, the lawsuit claims Bayer has not disclosed what criteria it uses to determine whether a refund should be issued to consumers who purchased the contaminated products.

The case looks to represent anyone in the U.S. who purchased the Lotrimin or Tinactin anti-fungal sprays listed above.

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