D-0639-2025Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-09-17

Distribution

Nationwide in the USA

Firm state

Product quantity

N/A

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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

Product description

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01

Code / lot info

Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26

Other recalls SPEQ maps to Risk Management & CAPA

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.