Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

chlorproMAZINE Hydrochloride Tablets Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above...

Date: March 11, 2025
Company: Glenmark Pharmaceuticals Inc., USA
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.

Affected Products

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

Quantity: 8160 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report