The Recall Desk
HighFDA (Drugs)·D-0240-2022·Announced 2021-11-24

Lotrimin Daily Prevention Deo Spray Recalled for Benzene Contamination Risk

Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was 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 potential chemical contamination (benzene) from facility deviations. While no reported illnesses or injuries are stated in the source, the hazard involves a known toxic substance at a facility with confirmed contamination history, placing this at the High level per the rubric.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray in 160g (5.6 oz) cans. The recall affects 579,456 units distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.

The recall was initiated 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, a chemical known to pose health risks.

Affected lots include single-pack and 3-pack configurations with various lot numbers and expiration dates ranging from January 2022 through August 2022. Consumers should stop using the product and contact Bayer Healthcare for instructions on how to return it or dispose of it safely.

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
  • chemical-exposure
  • manufacturing-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)TN0023C
  • EXP 1/31/2022
  • TN003C7
  • EXP 4/30/2022
  • TN00570
  • EXP 7/31/2022
  • TN0056Z
  • TN005KJ
  • EXP 8/31/2022
  • (b)TN0023C
  • EXP 01/31/2022
  • EXP 04/30/2022
  • TN0023DV
  • TN0023DAV
  • TN0023DBV
  • TN0023DC
  • EXP 02/28/2022
  • TN005KJA
  • TN005KJB
  • EXP 08/31/2022

UPCs (2)

  • 041100587206
  • 041100589613

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · LOTRIMIN DAILY PREVENTION DEO

Same category