Benzene found in Bayer antifungal spray drugs

Bayer has issued a recall of the spray formulations of its Tinactin and Lotrimin antifungal treatments because of benzene contamination. The Oct. 1 recall covers cans with lot numbers starting with TN, CV, or NAA, which would have been in stores between September 2018 and September 2021.

The Bayer recall marks the third time this year that benzene, a known carcinogen, has been found in consumer health products. The independent analytical lab Valisure found benzene in 65 batches of hand sanitizer in March and 78 sunscreens and sun aftercare lotions in June. Several sunscreens were recalled or pulled from store shelves, including Coppertone products on Sept. 30. The US Food and Drug Administration has warned the public not to use several brands or types of alcohol-based hand sanitizers. Valisure was not involved in the discovery of benzene in Bayer’s antifungals.

Valisure CEO David Light says the source or sources of benzene in these products is still unknown. Ethanol, which is in all of the recalled Bayer products and most of the earlier products, is one possible culprit. Benzene is a known impurity in petroleum-derived ethanol and is sometimes used to denature industrial ethanol or make it anhydrous. Propellants, carbomer gelling agents, and mineral ingredients are also suspects, Light says.

“The raw materials for many of these consumer products are a significant source of vulnerability for the overall pharmaceutical supply chain,” Light says. “It seems our initial discovery of benzene was just the tip of the iceberg, and it’ll likely take some time to understand just how deep it goes.”