Drug recall D-0633-2025

Class II Ongoing reported Sep 17, 2025

Product

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01

Reason for recall

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

Lots and codes

Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
N/A
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
September 3, 2025

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