Major Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination concerns. A foreign substance was found in the packaging material, although the tablets themselves remain unaffected. Consumers should stop using the product immediately and consult 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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The recall involves Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, in blister packs containing 100 tablets. The affected lot is Lot # N02309, with an expiration date of March 31, 2027.
The recall stems from the detection of a micro-organism in a specific lot of polyester coil used for product packaging. No micro-organism was found on the tablets themselves.
There have been no reported incidents of illness or injury linked to this product. The risk remains elevated due to the potential for contamination.
Consumers should stop using the medication immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance.
For more information, consumers can visit the recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0624-2025.
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