Cardinal Health recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination risks. A specific lot contained a foreign substance with a detected micro-organism, although no contamination was found on the tablets. Consumers must stop using the product immediately and seek guidance from 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
The recalled product is Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, in unit dose blister packs. It is distributed by Cardinal Health, Dublin, OH, and identified under NDC 55154-7895-0. The affected inner blister lot is N02309, with an expiration date of March 31, 2027.
The recall stems from the presence of a micro-organism detected in an auxiliary polyester coil used in the product's packaging. This poses a potential health risk, classified as Class II by the FDA.
There are no reported incidents of contamination on the tablets themselves, and no injuries have been documented related to this recall.
Stop using the product immediately. Consumers should contact The Harvard Drug Group, LLC, or their healthcare provider for further guidance. A notification letter will be sent to affected parties.
For more information, consumers can reach The Harvard Drug Group, LLC at their website or by phone. Details about the recall are also available on the FDA's website.
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