FDA Recall D-0361-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 406 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 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

Lot / code: Lot #: Z400069, Exp.: 12/31/2025

Quantity: 3144 bottles, pack size: 100's Count

Reason for recall

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

Recall record

Recall number: D-0361-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Recall initiated: 2025-04-03
Classified by FDA Center: 2025-04-10
FDA published: 2025-04-16
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): CHLORPROMAZINE HYDROCHLORIDE
Generic name(s): CHLORPROMAZINE HYDROCHLORIDE
Manufacturer(s): Zydus Pharmaceuticals (USA) Inc.
NDC(s): 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133
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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