Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zy...
FDA Recall #D-0636-2025 — Class II — September 3, 2025
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
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 #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated