The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per…

Recall date

September 2, 2025

Source

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

Recall number

D-0624-2025

FDA classification

Class II

Brand / firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold / distributed

USA Nationwide.

Why it was recalled

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61