The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0248-2022·Announced 2021-11-24

Lotrimin AF Powder Spray Recalled for Benzene Contamination

Bayer Healthcare is recalling Lotrimin AF miconazole nitrate 2% powder spray due to the presence of benzene chemical contamination. The recall affects approximately 3.8 million cans distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I by the agency, which mandates a severity score of at least 4. Benzene is a known carcinogen and a chemical contaminant in an inhalable drug product represents a serious health risk to users.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF (miconazole nitrate 2%) powder spray in 133g (4.6 oz) cans due to chemical contamination. The recalled product contains benzene, a harmful chemical that should not be present in the medication.

The affected product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. The recall involves specific lot numbers: CV01AP2 (expiration 2/28/2022), TN006TD (expiration 3/31/2023), TN008CV (expiration 4/30/2023), and TN008CW (expiration 5/31/2023). The product is identified by NDC 11523-0544-2 and UPC 3 11017 41025 7.

Consumers who have purchased this product should stop using it immediately. Those with questions or concerns should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical antifungal spray
Hazard
Affected units
3,816,468

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 (8)

  • Lot # CV01AP2
  • EXP 2/28/2022
  • TN006TD
  • EXP 3/31/2023
  • TN008CV
  • EXP 4/30/2023
  • TN008CW
  • EXP 5/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Bayer Healthcare Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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