Major Pharmaceuticals recalls sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets sold nationwide. A specific lot of packaging coil used in production was found to contain a microorganism in the packaging area, though no microorganism was detected on the tablets. Consumers should stop using the product and follow guidance from Major Pharmaceuticals or their healthcare provider.
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.
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
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This medication is a commonly prescribed antibiotic used to treat bacterial infections. The product comes in 800 mg/160 mg double-strength tablets and is Rx only.
The hazard involves a foreign substance in packaging materials. A microorganism was detected in the auxiliary polyester coil used in packaging. The tablets themselves tested negative for microorganisms.
This recall is not described as part of a broader industry pattern.
The recall may cause temporary treatment delays for patients who were prescribed this antibiotic. Consumers should discontinue use and seek guidance from a clinician.
Recall notices and supplier statements should be available from Major Pharmaceuticals and the FDA enforcement database (D-0624-2025)
Recall processing outcomes and refunds or replacements, if offered, will follow the company’s recall procedure
Keep the recall letter, packaging, and any correspondence with the supplier for records
Product: Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg double-strength, 100 tablets per carton, unit-dose blister packs (10x10). Rx only. NDC 0904-2725-61. Distributor: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Packaged by Amneal Pharmaceuticals LLC. Sold nationwide in the USA. Recall date: 2025-09-02. Report date: 2025-09-17. Lot: N02309. Expiration: 03/31/2027.
No injuries or incidents have been reported.
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