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Drug FDA Class II Ongoing cGMP deviation

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

Glenmark Pharmaceuticals Inc., USA Published Apr 9, 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 Glenmark Pharmaceuticals Inc., USA 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 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

CHLORPROMAZINE HYDROCHLORIDE · 8160 bottles

NDC: 68462-861, 68462-862, 68462-863, 68462-864, 68462-865, 68462-861-01, 68462-861-10, 68462-862-01, 68462-862-10, 68462-863-01, 68462-863-10, 68462-864-01, 68462-864-10, 68462-865-01, 68462-865-10
Code info: Lot#s: 17232222 and 17232237, Exp 10/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 11, 2025
  2. Published
    Apr 9, 2025
Recall number
D-0309-2025
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.