FDA-Drug2025-09-10Class II
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Hazard
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.
Sold states
Distributed Nationwide in the USA
Affected count
60,072 100-count, 73,054 500-count bottles
Manufactured in
400 Crossing Blvd Fl 3, N/A, Bridgewater, NJ, United States
Products
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0615-2025More Amneal Pharmaceuticals, LLC recalls
- FDA-Drug2026-06-17Amneal Primidone tablets recalled for potential cross-contamination with Acemetacin
- FDA-Drug2026-04-08Amneal Pharmaceuticals tramadol 50 mg tablets recalled for elevated impurity levels
- FDA-Drug2026-04-08Amneal Magnesium Sulfate IV bags recalled due to wrong medication inside packaging
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