FDA Recall D-0616-2025

Amneal Pharmaceuticals, LLC · Bridgewater, NJ

Class II Ongoing 269 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.

Lot / code: Lot AM240617, AM240618, Exp Date 04/30/2027

Quantity: 7,228 100-count bottles

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.

Recall record

Recall number: D-0616-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-08-18
Classified by FDA Center: 2025-09-04
FDA published: 2025-09-10
Recalling firm: Amneal Pharmaceuticals, LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): CHLORPROMAZINE HYDROCHLORIDE
Generic name(s): CHLORPROMAZINE HYDROCHLORIDE
Manufacturer(s): Amneal Pharmaceuticals NY LLC
NDC(s): 69238-1054, 69238-1056, 69238-1058, 69238-1060, 69238-1062
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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