Tinactin Tolnaftate Spray Recalled for Potential Benzene Contamination
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) liquid spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for potential contamination by benzene, a known human carcinogen. Although no illnesses or injuries are reported, benzene poses a significant health risk even at low levels of exposure, which justifies a High severity rating.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) liquid spray (150g/5.3 oz cans) due to potential benzene contamination. The recall is prompted by cGMP deviations—the product was manufactured at the same facility where other lots were found to be contaminated with benzene.
The affected product includes cans manufactured in Finland and Ireland with various lot numbers and expiration dates ranging from July 2021 through February 2023. The product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through a variety of retail channels.
Consumers who have purchased this product should stop using it. Consumers with questions about the recall may contact Bayer Healthcare's consumer care line at the phone number on the product packaging.
The recalled product
- Product
- TINACTIN (TOLNAFTATE)
- Brand
- TINACTIN
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug — Topical OTC Drug
- Hazard
- benzene-contamination
- 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 (20)
- Lot # (a)TN0060U
- TN0060V
- TN0060W
- EXP 7/31/2022
- TN0060X
- TN0060Y
- TN0060Z
- TN006CJ
- TN006CK
- TN006CM
- TN00610
- EXP 9/30/2022
- TN006YW
- EXP 10/31/2022
- TN006MY
- TN006YX
- TN006YY
- EXP 12/31/2022
- TN007EN
- TN007EP
UPCs (2)
- 0311017410059
- 311017410059
Distribution
Distributed nationwide across the United States.
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