The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0244-2022·Announced 2021-11-24

Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination

Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 classified this as a Class II recall. Benzene is a known carcinogen and systemic toxicant that poses a serious health risk, particularly through inhalation from a spray product. Although no specific illness or injury reports are stated in the source text, the hazard itself—contamination with a carcinogenic substance—meets the threshold for Severe under the rubric's criteria for hazardous substances with potential for significant harm.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Jock Itch Powder Spray in 133g (4.6 oz) cans. A total of 592,416 cans are affected by this recall.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations. The product was manufactured at the same facility where other lots were found to be contaminated with benzene.

The affected product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through a variety of retail channels. The affected lot numbers are TN00086 (CV015YU, expiration 10/31/2022), TN00273 (expiration 12/31/2022), and TN005RW (expiration 5/31/2023).

Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist with questions.

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 Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Over-the-counter topical antifungal
Hazard
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 (7)

  • Lot # TN00086
  • CV015YU
  • EXP 10/31/2022
  • TN00273
  • EXP 12/31/2022
  • TN005RW
  • Exp 5/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 19 products in this recall →

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