The Recall Desk
ModerateFDA (Drugs)·D-0254-2022·Announced 2021-11-24

Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Potential Benzene Contamination

Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF Daily Prevention deodorant powder spray due to cGMP deviations at the manufacturing facility where other lots were found contaminated with benzene.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a manufacturing facility deviation where contamination was found in other lots. No actual illnesses or injuries have been reported, and the contamination risk is associated with facility-wide deviations rather than confirmed product contamination, making this a moderate-severity precautionary recall.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, 160g (5.6 oz) cans. The product was manufactured at a facility where other lots were found to be contaminated with benzene, indicating cGMP (current good manufacturing practice) deviations.

The recalled product includes specific lot numbers: NAA8997 (expiration 01/31/2022), NAA8EK8 (expiration 02/28/2022), NAA9E18, NAA9LFP, NAA9T53, and NAA5RW (expiration 08/31/2022). Approximately 579,456 units were distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.

Consumers who have purchased the affected product should stop use and contact Bayer Healthcare Pharmaceuticals for further instructions. The product is a topical OTC drug used for fungal infection prevention.

The recalled product

Product
LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
Brand
LOTRIMIN DAILY PREVENTION DEO
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical OTC Drug
Hazard
  • benzene-contamination
  • cgmp-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 (9)

  • Lot # NAA8997
  • EXP 01/31/2022
  • NAA8EK8
  • EXP 02/28/2022
  • NAA9E18
  • NAA9LFP
  • NAA9T53
  • NAA5RW
  • EXP 08/31/2022

UPCs (2)

  • 041100587206
  • 011017408239

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · LOTRIMIN DAILY PREVENTION DEO

Same category