The Department of Public Health and Social Services (DPHSS), in coordination with the U.S. Food and Drug Administration (USFDA), would like to inform the public of a voluntary recall by Bayer of specific Lotrimin® and Tinactin® spray products due to the presence of benzene.
Bayer 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, due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.
As per the USFDA, benzene is classified as a human carcinogen. 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. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to the substance from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.
The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo-packs, packaged in aerosol spray cans. The impacted products are:
- 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
A complete listing of affected product names, lot numbers, expiry dates, and images are included as an attachment to this press release.
There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.
The Division of Environmental Health (DEH) of DPHSS was notified by two retailers (Guam Rexall Drugs, located in Tamuning, and Super Happy Mart, located in Barrigada), that they had the affected products on hand. Guam Rexall Drugs removed 51 of the affected products, while Super Happy Mart removed one affected product from store shelves.
To date, DEH has determined that the affected Lotrimin® AF and Tinactin® aerosol spray cans were sold at the aforementioned retailers:
|Lotrimin AF JI Spray Powder 133g 36 pk||TN007TG||2023-03-31||Guam Rexall Drugs|
|Lotrimin Liquid Spray 133g (4.6oz)||TN006MC||2023-01-31||Guam Rexall Drugs|
|Lotrimin AF Powder Spray 133g 36pk||TN006MJ||2022-09-30||Guam Rexall Drugs|
|Lotrimin AF Deo Powder Spray 133g 36 pc||TN006MZ||2023-02-28||Guam Rexall Drugs|
|Lotrimin AF Powder Spray 133g (3 Pack)||TN005P4||2022-08-31||Guam Rexall Drugs|
|Tinactin JI Spray 133g||TN005RW||2023-05-31||Guam Rexall Drugs|
|Tinactin AF Powder Spray 133g||TN006AT||2022-12-31||Guam Rexall Drugs|
|Tinactin AF Powder Spray 133g||TN006TA||2023-02-28||Guam Rexall Drugs|
|Tinactin AF Powder Spray||CV01AE7||2022-02-28||Super Happy Mart|
DEH continues to conduct its recall effectiveness check activities and will continue to update the public as more information is obtained.
The Department has not received any local report of injuries or illnesses associated with the use of these recalled commodities. Anyone concerned about a reaction should contact their healthcare provider. Consumers who have purchased the items listed above are urged not to use the affected products.
A copy of the recall, which includes instructions for requesting a refund, is available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene.
For any questions, please contact the Consumer Commodities Program at DEH at 300-9579.