Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to potential benzene contamination. The product was manufactured at a facility where other lots tested positive for benzene.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a drug product. Although no illnesses are reported in the source text, the hazard—benzene contamination—is a serious carcinogen. The facility-wide cGMP deviation with confirmed contamination in other lots justifies a Severe classification.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray, a topical antifungal product sold in 133g (4.6 oz) cans. The recall affects approximately 738,432 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.
The recall was initiated because the product was manufactured at a facility where other lots were found to be contaminated with benzene, a known carcinogen. Affected lots include TN004BW (expiration 7/31/2022), TN00678 (expiration 8/31/2022), and TN00679 (expiration 9/30/2022).
Consumers who have purchased this product should stop using it. Those who have used the product and have health concerns should consult a healthcare provider. For additional information, consumers may contact Bayer Healthcare or check the FDA website for updates on this recall.
The recalled product
- Product
- TINACTIN (TOLNAFTATE)
- Brand
- TINACTIN
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- benzene-contamination
- carcinogen
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # (a) TN004BW
- EXP 7/31/2022
- (b) TN00678
- EXP 8/31/2022
- TN00679
- EXP 9/30/2022
UPCs (2)
- 0311017410004
- 311017410004
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TINACTIN
- HighTinactin Tolnaftate Spray Recalled for Potential Benzene Contamination
FDA (Drugs) · 2021-11-24
- SevereTinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-11-24
- SevereTinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-11-24
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