Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zy...
FDA Recall #D-0638-2025 — Class II — September 3, 2025
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
Reason for Recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recalling Firm
Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA
Code Information
Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated