Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N
Recalled September 10, 2025 · FDA recall D-0615-2025 · 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
60,072 100-count, 73,054 500-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
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Manufacturer(s)
Amneal Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →