Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can Recalled by Bayer Healthcare Pharmaceuticals Inc. Due to cGMP Deviations: manufactured at the same facility where...

Date: October 1, 2021
Company: Bayer Healthcare Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bayer Healthcare Pharmaceuticals Inc. directly.

Affected Products

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

Quantity: 1,801,332 cans

Why Was This Recalled?

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bayer Healthcare Pharmaceuticals Inc.

Bayer Healthcare Pharmaceuticals Inc. has 20 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report