Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination
Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.
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: The FDA classified this as a Class I recall, which per the rubric requires a minimum severity score of 4. Benzene is a known carcinogen and chemical contaminant that presents serious potential health risk, meeting the criteria for a Severe classification.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Liquid Spray in 150g (5.3 oz) cans due to the presence of benzene, a chemical contaminant. The recalled product includes cans manufactured in Finland (Lot #TN006MX, EXP 10/31/2022; TN00BKV, TN008D1, TN008D2, EXP 3/31/2023) and Ireland (Lot #CV0180B, EXP 12/31/2021; TN003C5, EXP 1/31/2023). The UPC is 3 11017 41005 9 and the NDC is 11523-0165-3.
The product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. A total of 4,990,860 cans are affected by this recall.
Consumers who have purchased this product should stop using it and contact Bayer Healthcare for further instructions. Exposure to benzene can present serious health risks. Anyone with questions about this recall should contact the company through the FDA's recall page.
The recalled product
- Product
- TINACTIN (TOLNAFTATE)
- Brand
- TINACTIN
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug — Topical OTC
- Hazard
- benzene
- chemical-contamination
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 (10)
- Lot # (a)TN006MX
- EXP 10/31/2022
- TN00BKV
- TN008D1
- TN008D2
- EXP 3/31/2023
- (b) CV0180B
- EXP12/31/2021
- TN003C5
- EXP 1/31/2023
UPCs (2)
- 0311017410059
- 311017410059
Distribution
Distributed nationwide across the United States.
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