Tinactin Tolnaftate Jock Itch Powder Spray Recall Due to Benzene Contamination
Bayer Healthcare is recalling Tinactin Tolnaftate 1% Jock Itch Powder Spray due to the presence of benzene contamination. The product was distributed nationwide in the US, Puerto Rico, Canada, and Mexico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall, which by the rubric criteria requires a minimum severity score of 4. Benzene is a known carcinogen and hazardous chemical contaminant, making this a severe public health concern even without reported illnesses.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Jock Itch Powder Spray, 133g (4.6 oz) cans, due to the presence of benzene chemical contamination. The affected product was manufactured in Finland and distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels.
The specific recalled lot is Lot #TN008M0 with an expiration date of 4/30/2023. The product NDC number is 11523-0072-5, and the UPC is 3 11017 41007 3. Approximately 592,416 cans are subject to this recall.
Consumers who have purchased this product should stop using it and contact Bayer Healthcare for further instructions. Those with questions about the recall or the product may reach out to the company or consult with healthcare providers.
The recalled product
- Product
- Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug — Topical Antifungal
- Affected units
- 592,416
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 (2)
- Lot # TN008M0
- EXP 4/30/2023
Distribution
Part of a larger recall action
This product is one of 19 recalled by Bayer Healthcare Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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