LOTRIMIN AF — Class II drug recall D-0238-2022
Terminated recall by Bayer Healthcare Pharmaceuticals Inc., reported 2021-11-24, distributed nationwide. cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene
| Recall number | D-0238-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United States |
| Recall initiated | 2021-10-01 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 3,816,468 cans |
| Reason classes | chemical contamination, cgmp |
| UPC / GTIN / UDI-DI | 00041100585943, 00311017410257 |
| NDC | 11523-0544-02 |
| Lot numbers | CV017D9, CV01940, CV01940A, CV01AP2, CV01CD9, CV01D9T, CV01D9TA, CV01DZ3, CV01EPP, TN000TT, TN000TTA, TN003CG, TN003CH, TN003CHA, TN00407, TN00407A, TN0041V, TN0056W, TN005P4, TN006MJ, TN006TD, TN006TDB |
| Expiration dates | 2021-10-31, 2021-11-30, 2022-02-28, 2022-04-30, 2022-06-30, 2022-07-31, 2022-08-31, 2022-09-30, 2022-10-31, 2023-01-31, 2023-03-31, 2023-06-30 |
Product
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
Reason for recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0238-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.