The Recall Desk
HighFDA (Drugs)·D-0237-2022·Announced 2021-11-24

LOTRIMIN AF Jock Itch Powder Spray Recalled for Benzene Contamination

Bayer Healthcare is recalling LOTRIMIN AF Jock Itch Powder Spray (Miconazole nitrate 2%, 4.6 OZ cans) distributed nationwide due to manufacturing facility cGMP deviations where other lots were found to be contaminated with 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: This is an FDA Class II recall of a drug product where the hazard—benzene contamination—is a known toxic substance. Although no illnesses are explicitly reported in the source text, benzene poses significant health risk, and the contamination was identified at the manufacturing facility (not merely theoretical). This meets the "High" threshold for a risk-of-harm drug product where no illness has yet been reported.

Plain-English summary

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray in 133g (4.6 OZ) cans is being recalled by Bayer Healthcare Pharmaceuticals Inc. The recall affects approximately 4,546,152 cans that were distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility. Other lots of product manufactured at the same facility were found to be contaminated with benzene, a known toxic chemical.

Consumers who have purchased this product should stop using it and consult with a healthcare provider if they have health concerns. The affected product can be identified by NDC 11523-4140-2 and UPC 3 11017 41031 8. Multiple lot numbers are affected, including lots CV01BEP through TN004BU with expiration dates ranging from March 2022 through September 2023.

The recalled product

Product
LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
Hazard
  • benzene-contamination
  • manufacturing-defect

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 #: CV01BEP
  • 3/31/2022
  • CV01D6W
  • 5/31/2022
  • CV01EV0
  • 7/31/2022
  • TN0004J
  • 9/30/2022
  • TN001AE
  • 11/30/2022
  • TN003C3
  • 1/31/2023
  • TN003C4
  • 2/28/2023
  • TN003HT
  • 3/31/2023
  • TN003CW
  • 4/30/2023
  • TN0045J
  • 6/30/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category