Class II

Drug Recall: chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

Glenmark Pharmaceuticals Inc., USA · December 11, 2024

Reason for Recall

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Distribution

USA Nationwide

States Affected

NATIONWIDE

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0160-2025

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.