# FDA recall D-0243-2022

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

## Product

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of  Ireland 87022897,  (c)  Product of  Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3     Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can,  Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981,  UPC 3 11017 41005 9, NDC 11523-0165-3.

## 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-0243-2022
- **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-0243-2022

## Citation

> AI Analytics. FDA recall D-0243-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0243-2022. Source: US FDA. Licensed CC0.

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