A high-risk recall of sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets is active nationwide in the United States. The Harvard Drug Group and distribution partners have halted use of a lot due to a foreign-substance finding in packaging material. No tablets tested positive for micro-organisms. Consumers should stop using the product and consult their healthcare providers.
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 antibiotic combines sulfamethoxazole and trimethoprim for bacterial infections. It is used under medical supervision and is distributed nationwide.
A foreign-substance material in packaging raises contamination concerns. No tablets were contaminated.
This recall is not part of a broader industry recall pattern.
Immediate stop-use is required; potential supply disruption for patients needing antibiotics.
FDA enforcement recall page D-0625-2025 and FDA enforcement report with recall number D-0625-2025
Remedy delivery via recall notification letters; refunds/replacements governed by distributor policies
Keep recall notice, take photos of packaging and lot numbers, note dates of receipt
Product: Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg double strength, 10 tablets per blister pack (10x1) per bag. Distributors: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Distributed by Cardinal Health, Dublin, OH 43017. NDC: 55154-7895-0. Outer bag contains NDC 0904-2725-61 in inner blisters. Lot: N02309. Bag identifiers: Bag N02309A and N02309B.
No injuries or incidents have been reported.
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