Product: 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
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 initiated: 20250902
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated