The Recall Desk
SevereFDA (Drugs)·D-0238-2022·Announced 2021-11-24

LOTRIMIN AF Powder Spray Recalled for Benzene Contamination Risk

Bayer Healthcare is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray because it was manufactured at a facility where other lots were found contaminated with benzene. The recall affects multiple lot numbers 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: This is an FDA Class II recall involving a known contamination hazard (benzene) at a manufacturing facility. Benzene is a known carcinogen and reproductive/developmental toxicant, making this a serious manufacturing defect that warrants a Severe classification even though no reported illnesses are stated in the source text.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray in 133g (4.6 oz) cans due to cGMP (current Good Manufacturing Practice) deviations. The affected product was manufactured at the same facility where other lots were found to be contaminated with benzene.

The recall involves specific lot numbers with expiration dates ranging from October 2021 through June 2023. The product was 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 immediately. Consumers with questions or concerns should contact Bayer Healthcare or consult their healthcare provider.

The recalled product

Product
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
Hazard
  • benzene-contamination
  • cGMP-deviations

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) CV017D9
  • EXP 10/31/2021
  • CV01940
  • EXP 11/30/2021
  • CV01CD9
  • EXP 4/30/2022
  • CV01D9T
  • CV01DZ3
  • EXP 6/30/2022
  • CV01EPP
  • EXP 7/31/2022
  • TN000TT
  • EXP 10/31/2022
  • TN003CG
  • EXP 1/31/2023
  • TN003CH
  • TN00407
  • EXP 3/31/2023
  • TN0041V
  • EXP 6/30/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category