Sulfamethoxazole and Trimethoprim Tablets recalled over sterility concerns

Recall date

June 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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)…

Recall number

D-0488-2025

FDA classification

Class I

Brand / firm

Amneal Pharmaceuticals, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.