Amneal Pharmaceuticals recalled over 133,000 bottles of Sulfamethoxazole and Trimethoprim Tablets on August 18, 2025. The recall stems from the detection of a microorganism in the packaging material, raising health concerns. No microorganisms were found on the tablets themselves.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging 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 Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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The recall includes Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg packaged in 100-count bottles (NDC 65162-272-10) and 500-count bottles (NDC 65162-272-50). A total of 60,072 100-count and 73,054 500-count bottles are affected.
The recall was issued due to the presence of a microorganism detected in a specific lot of auxiliary polyester coil used in packaging. There were no reported microorganisms found on the tablets.
No injuries or illnesses related to the recall have been reported to date. The presence of a microorganism in the packaging could potentially pose health risks.
Consumers should stop using the product immediately and contact Amneal Pharmaceuticals or their healthcare provider for further guidance. A notification letter will be sent to affected consumers.
For assistance, contact Amneal Pharmaceuticals, LLC at their designated customer service number or visit their website for more information.
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