The Recall Desk
SevereFDA (Drugs)·D-0236-2022·Announced 2021-11-24

LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

What this means for you

Illness, injury, or structural failure has been reported. 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 hazardous substance, and the contamination resulted from manufacturing deviations at a facility with confirmed contamination in other lots, which constitutes a serious manufacturing control failure meeting the Severe threshold for FDA Class II recalls with significant hazard implications.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, 133g (4.6 oz) cans, due to cGMP (current good manufacturing practice) deviations. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

The affected recall involves multiple lot codes with various expiration dates ranging from September 2021 through February 2023. Approximately 2,817,468 cans were distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels.

Consumers who have purchased this product should stop using it. Those with questions or concerns about the recall should contact Bayer Healthcare Pharmaceuticals Inc. or consult their healthcare provider.

The recalled product

Product
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical antifungal
Hazard
  • benzene-contamination
  • 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 # TN00082
  • Exp 9/30/2021
  • TN000TU
  • TN000TV
  • Exp. 10/31/2021
  • TN00236
  • Exp. 1/31/2022
  • TN003C8
  • Exp 2/28/2022
  • TN003C9
  • Exp 3/31/2022
  • TN003GS
  • Exp 4/30/2022
  • TN0041W
  • Exp 6/30/2022
  • TN006W8
  • Exp 8/31/2022
  • TN005P5
  • Exp 9/30/2022
  • TN006MZ

Distribution

Distributed nationwide across the United States.

Related recalls

Same category