# FDA recall D-0241-2022

> **Bayer Healthcare Pharmaceuticals Inc.** · Class II · drug recall initiated 2021-10-01.

## Product

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

## Reason for recall

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

## Distribution

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

## Key facts

- **Recall number:** D-0241-2022
- **Recalling firm:** Bayer Healthcare Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-01
- **Report date:** 2021-11-24
- **Termination date:** 2023-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Whippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0241-2022

## Citation

> AI Analytics. FDA recall D-0241-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0241-2022. Source: US FDA. Licensed CC0.

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