MedicineWatch US
Class II Recall

Zydus Pharmaceuticals (USA) Inc

Product
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
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Classification
Class II
Status
Ongoing
Lot
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
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Zydus Pharmaceuticals (USA) Inc — Class II Recall | MedicineWatch US