FDA Drug Recalls

Recalls / Active ingredient / Sulfamethoxazole

Sulfamethoxazole

10 FDA drug recalls involving the active ingredient “Sulfamethoxazole1 Class I.

DateClassProductFirm
2025-09-02Class IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
2025-09-02Class IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10xThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
2025-08-20Class IISulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NNorthwind Pharmaceuticals LLC
2025-08-18Class IISulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-countAmneal Pharmaceuticals, LLC
2025-06-02Class ISulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-2Amneal Pharmaceuticals, LLC
2022-04-13Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major PharMckesson Medical-Surgical Inc. Corporate Office
2021-07-07Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, DistributeAurobindo Pharma USA Inc.
2020-08-10Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx OnlyAurobindo Pharma USA Inc.
2018-04-19Class IISulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioSun Pharmaceutical Industries, Inc.
2011-09-27Class IISulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to containShamrock Medical Solutions Group LLC