Reported Nov 24, 2021 · Terminated

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100…

Bayer Healthcare Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bayer Healthcare Pharmaceuticals Inc. · 100 Bayer Blvd · Whippany, NJ · 07981-1544

Is this the product you have?

  • 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 byBayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
Lot codes and dates

16 of 16 products

Products covered by this recall
#Product as published
1Lot # (a) TN000TR, EXP 10/31/2021
2TN0011B, EXP 11/30/2021
3TN003CC, TN003CD, EXP 02/28/2022
4TN0040B, EXP 05/31/2022
5TN0041U, EXP 06/30/2022
6TN004BK, EXP 08/31/2022
7TN005P3, EXP 10/31/2022
8TN006AP, TN006MC, EXP 01/31/2023
9TN006TB, EXP 04/30/2023
10(b) TN000TR, EXP 10/31/2021
11TN0011B, TN0011BA, EXP 11/30/2021
12TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022
13TN0040BA, TN0040BV, EXP 05/31/2022
14TN0041U,EXP 06/30/2022
15TN004BK, EXP 08/31/2022
16TN006MC, EXP 01/31/2023
Amount recalled
1,801,332 cans

This recall covers 19 products

The agency filed one notice per product. You are reading one of them; the other 18 are below.

6 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 26, 2023 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.