The Recall Desk
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.

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 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
  • benzene-contamination
  • manufacturing-defect

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.

Related recalls

Same brand · LOTRIMIN DAILY PREVENTION DEO

Same category