Class II

Drug Recall: 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 · March 11, 2025

Reason for Recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Distribution

Nationwide in the USA and PR

States Affected

NATIONWIDE

Quantity Affected

8160 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0309-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.