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Drug FDA Class II Ongoing cGMP deviation

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

Zydus Pharmaceuticals (USA) Inc Published Sep 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

N-Nitroso Desmethyl Chlorpromazine · primary

Affected products (1)

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

CHLORPROMAZINE HYDROCHLORIDE · N/A

NDC: 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133, 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4
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

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 3, 2025
  2. Published
    Sep 17, 2025
Recall number
D-0638-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.