# FDA recall D-0361-2025

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2025-04-03.

## Product

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

## Reason for recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

## Distribution

Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA

## Key facts

- **Recall number:** D-0361-2025
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-03
- **Report date:** 2025-04-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0361-2025

## Citation

> AI Analytics. FDA recall D-0361-2025. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/D-0361-2025. Source: US FDA. Licensed CC0.

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