Class IIReported 2025-09-17

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

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason for Recall

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.

Recall Number

D-0624-2025

Classification

Class II

Status

Ongoing