Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Recalled June 18, 2025 · FDA recall D-0488-2025 · Amneal Pharmaceuticals
Hazard
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. · FDA Class I
Units
6396 bottles
Sold at
Nationwide in the USA
Description
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Product
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, 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 →