The Recall Desk
HighFDA (Drugs)·D-0241-2022·Announced 2021-11-24

Lotrimin AF Liquid Spray Recalled for Potential Benzene Contamination

Bayer Healthcare is recalling Lotrimin AF Miconazole nitrate 2% Liquid Spray nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to contain 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: The source states the product was manufactured at a facility where other lots were found contaminated with benzene, a known carcinogen. The source text contains no report of illnesses or injuries, making this a theoretical risk of harm. Per the rubric, this qualifies as High severity.

Plain-English summary

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

The recalled product includes single-pack cans (UPC 0 41100 40788 7, NDC 11523-4327-1) and 3-pack boxes (UPC 0 41100 58593 6), with multiple lot numbers and expiration dates ranging from October 2021 through April 2023. A total of 1,801,332 cans have been distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.

Consumers who have purchased this product should stop using it. Those with questions or concerns should contact Bayer Healthcare LLC at the address listed on the product packaging.

The recalled product

Product
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
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 (20)

  • Lot # (a) TN000TR
  • EXP 10/31/2021
  • TN0011B
  • EXP 11/30/2021
  • TN003CC
  • TN003CD
  • EXP 02/28/2022
  • TN0040B
  • EXP 05/31/2022
  • TN0041U
  • EXP 06/30/2022
  • TN004BK
  • EXP 08/31/2022
  • TN005P3
  • EXP 10/31/2022
  • TN006AP
  • TN006MC
  • EXP 01/31/2023
  • TN006TB
  • EXP 04/30/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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