The Recall Desk
HighFDA (Drugs)·D-0245-2022·Announced 2021-11-24

Tinactin Tolnaftate Powder Spray Recalled for Potential Benzene Contamination

Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Powder Spray due to potential benzene contamination from cGMP deviations at the manufacturing facility. The recall affects approximately 2.8 million cans distributed nationwide and internationally.

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 involving a potentially serious contaminant (benzene, a carcinogen) at the manufacturing facility. Although no specific illnesses or injuries are reported in the source text, benzene exposure poses a significant risk of harm, placing this at the High severity level per the rubric.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Powder Spray in 133g (4.6 oz) cans due to cGMP (current Good Manufacturing Practice) deviations. The product was manufactured at a facility where other lots were found to be contaminated with benzene, a known carcinogen.

The recall affects approximately 2,841,012 cans with multiple lot numbers and expiration dates ranging from October 2021 through May 2023. Affected products are labeled as manufactured in Ireland or Finland and were distributed nationwide in the United States, as well as in Puerto Rico, Canada, and Mexico through various retail channels.

Consumers who have purchased this product should stop using it and consult with their healthcare provider if they have any health concerns. The product may be returned to the place of purchase for a refund or replacement.

The recalled product

Product
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
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) CV015YT
  • EXP 10/31/2021
  • CV01AE7
  • EXP 2/28/2022
  • CV01CY2
  • EXP 4/30/2022'
  • CV01E6P
  • EXP 8/31/2022
  • TN00085
  • TN001EK
  • EXP 10/31/2022
  • TN001ZV
  • TN00274
  • EXP 12/31/2022
  • TN003CU
  • EXP 1/31/2023
  • TN003CV
  • EXP 3/31/2023
  • TN0047H
  • EXP 4/30/2023

Distribution

Distributed nationwide across the United States.

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