Recall: D-0634-2025

Class II - Potentially Harmful

Class IIClassification

2025-09-03Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

Product

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1

Reason

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.