FDA recall D-0634-2025

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-09-03

Report date

2025-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2025