Amneal Pharmaceuticals recalled 60,072 100-count bottles and 73,054 500-count bottles of sulfamethoxazole and trimethoprim tablets. A foreign packaging material was detected in a lot, with no tablets contaminated. The recall is nationwide and ongoing as of the report date.
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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This antibiotic is used to treat bacterial infections. The double-strength tablet is prescribed for specific infections and dosages per clinician instruction.
A foreign packaging material fragment could contaminate the product packaging. Although no tablets were found contaminated, the potential risk warrants withdrawal from distribution.
This recall is not described as part of a broader pattern in the provided data.
Consumers may face interruption of antibiotic therapy and potential need for replacement at healthcare provider's guidance.
Label on bottle shows NDC and lot number. FDA recall notice provides lot and bottle size details.
Refunds or replacements will be arranged after recall notification by mail. Expect several weeks to process.
Save recall notice, take photographs of the bottle label, and keep all correspondence with the pharmacy and manufacturer
Product: Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg Double Strength. Packaging: 100-count bottle (NDC 65162-272-10) and 500-count bottle (NDC 65162-272-50). Manufacturer: Amneal Pharmaceuticals Pvt. Ltd, Ahmedabad, India. Distributor: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Lots involved: AM240173, AM240176, AM240177, AM240301, AM240300, AM240676, AM240677, AM240678, AM240679, AM240680, AM240921, AM240922, AM240923. Quantity recalled: 60,072 (100-count) and 73,054 (500-count). Distribution: Nationwide in the USA. Recall date: 2025-08-18. Report date: 2025-09-10.
No injuries or incidents have been reported.
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