# FDA recall D-0643-2025

> **AvKARE** · Class II · drug recall initiated 2025-08-25.

## Product

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

## Reason for recall

Presence of a foreign substance.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0643-2025
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-25
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2025

## Citation

> AI Analytics. FDA recall D-0643-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0643-2025. Source: US FDA. Licensed CC0.

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