# FDA recall D-0309-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-03-11.

## Product

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

## Reason for recall

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

## Distribution

Nationwide in the USA and PR

## Key facts

- **Recall number:** D-0309-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-11
- **Report date:** 2025-04-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2025

## Citation

> AI Analytics. FDA recall D-0309-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0309-2025. Source: US FDA. Licensed CC0.

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