Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P
Recalled September 10, 2025 · FDA recall D-0618-2025 · Amneal Pharmaceuticals
Hazard
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. · FDA Class II
Units
14,923 100-count bottles
Sold at
Distributed Nationwide in the USA
Description
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Product
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
Manufacturer(s)
Amneal Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →