Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv…

Recall date

August 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0617-2025

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals, LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

chlorproMAZINE Hydrochloride Tablets, USP, 50 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 69238-1058-1.