# FDA recall D-0618-2025

> **Amneal Pharmaceuticals, LLC** · Class II · drug recall initiated 2025-08-18.

## Product

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count  bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

## Reason for recall

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was   detected with presence of a micro-organism. No micro-organism was detected on any tablets.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0618-2025
- **Recalling firm:** Amneal Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-18
- **Report date:** 2025-09-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2025

## Citation

> AI Analytics. FDA recall D-0618-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0618-2025. Source: US FDA. Licensed CC0.

---

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