The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0239-2022·Announced 2021-11-24

Lotrimin Daily Prevention Deo recalled for potential benzene contamination

Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found 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 3/5 (High).

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 potential hazardous contaminant (benzene) without reported illnesses or injuries. The source explicitly indicates a risk-of-harm product where contamination was found at the manufacturing facility, placing it in the High severity category per the rubric.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, net weight 133g (4.6 oz), due to current Good Manufacturing Practice (cGMP) deviations. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

The recalled product includes lot numbers TN005K4 (expiration 4/30/2022) and TN005K8 (expiration 6/30/2022). A total of 77,076 cans were distributed nationwide in the US, Puerto Rico, Canada, and Mexico through a variety of retail channels. The product is identified by UPC 0 41100 59036 7 and NDC 11523-0010-1.

Consumers should stop using the product immediately. Consumers with questions may contact Bayer Healthcare Pharmaceuticals Inc. for additional information.

The recalled product

Product
LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
Brand
LOTRIMIN DAILY PREVENTION DEO
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical OTC antifungal
Hazard
Affected units
77,076

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 # TN005K4
  • EXP 4/30/2022
  • TN005K8
  • EXP 6/30/2022

UPCs (1)

  • 041100590367

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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Same brand · LOTRIMIN DAILY PREVENTION DEO

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Same hazard · benzene contamination

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