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Drug FDA Class II Ongoing cGMP deviation

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

Zydus Pharmaceuticals (USA) Inc Published Apr 16, 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 impurity above the recommended interim limit

Hazards

N-Nitroso-Desmethyl Chlorpromazine · primary

Affected products (1)

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

CHLORPROMAZINE HYDROCHLORIDE · 3144 bottles, pack size: 100's Count

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 #: Z400069, Exp.: 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 3, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0361-2025
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.