# FDA recall D-0635-2025

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2025-09-03.

## Product

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141.  NDC: 16714-049-01

## Reason for recall

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0635-2025
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-09-17

- **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-0635-2025

## Citation

> AI Analytics. FDA recall D-0635-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0635-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*