WhichRecall
Class IIReported 2025-09-17

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1

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-0636-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-03
Reported
2025-09-17
Distribution
Nationwide in the USA
Code Info
Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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