Major Pharmaceuticals recalls 100-tablet sulfamethoxazole-trimethoprim units due to foreign micro-organism in packaging. No tablets were contaminated. Consumers should contact the manufacturer for details.
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.
Major Pharmaceuticals is recalling a specific lot of sulfamethoxazole and trimethoprim tablets because packaging contained a micro-organism. This does not affect the tablets themselves, but the packaging issue requires action to prevent potential contamination.
The packaging material contained a micro-organism that could potentially contaminate the product. However, no micro-organism was found on the actual tablets, so the risk is limited to the packaging.
People who purchased the specific lot (N02309) of 100-tablet sulfamethoxazole-trimethoprim from Major Pharmaceuticals. Those with prescription for this medication are most at risk.
Check for the lot number N02309 on the packaging. The product is a 100-tablet unit dose blister pack (10x10) per carton, labeled as Rx only with NDC 0904-2725-61.
Look for the lot number N02309 on the packaging to confirm if the product is affected.
The tablets themselves were not contaminated with micro-organisms, but the packaging contained one. The product is safe to use if the packaging is checked for the specific lot number N02309.
Contact Major Pharmaceuticals directly for instructions on whether to return or discard the product. The recall does not specify a remedy.
The hazard is limited to potential packaging contamination, but no injuries have been reported. The risk is low as the micro-organism was not on the tablets.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0624-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0624-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.