WhichRecall
Class IIReported 2025-09-17

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

Recalled by Zydus Pharmaceuticals (USA) Inc

Reason for Recall

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

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Recall Number
D-0638-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-03
Reported
2025-09-17
Distribution
Nationwide in the USA
Code Info
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
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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