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 Zydus Pharmaceuticals (USA) Inc Due to CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above...

Date: September 3, 2025
Company: Zydus Pharmaceuticals (USA) Inc
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 Zydus Pharmaceuticals (USA) Inc directly.

Affected Products

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1

Quantity: N/A

Why Was This Recalled?

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.

Related Recalls

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