The Recall Desk
SevereFDA (Drugs)·D-0253-2022·Announced 2021-11-24

Tinactin Tolnaftate Powder Spray Recalled Due to Benzene Contamination

Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Powder Spray because some cans contain benzene contamination. Consumers should stop using affected lots and consult a healthcare provider.

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 recall as Class I, the most serious classification level. Per the rubric, FDA Class I recalls are scored no lower than 4, regardless of whether illnesses have been reported. The presence of benzene—a known carcinogen—in a product applied topically to skin represents a significant health hazard.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Powder Spray, a topical antifungal medication, due to the presence of benzene chemical contamination in certain lots.

The affected product is a 133g (4.6 oz) powder spray can sold under NDC 11523-0777-2. Two manufacturing origins and lot numbers are involved: cans marked "Product of Ireland" with lot number CV015YS (expiration 9/30/2021) and cans marked "Product of Finland" with lot numbers TN008CT and TN007TJ (expiration 3/31/2023).

Approximately 2,841,012 cans were distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. Consumers who have purchased this product should stop using it immediately and consult a healthcare provider if they have questions or concerns about their health following use.

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; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
Hazard
  • benzene-contamination
  • 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 (4)

  • Lot # (a)CV015YS
  • EXP 9/30/2021 (b) TN008CT
  • TN007TJ
  • EXP 3/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category