FDA Drug Recalls

Recalls / Active ingredient / Bupropion Hydrochloride

Bupropion Hydrochloride

22 FDA drug recalls involving the active ingredient “Bupropion Hydrochloride.

DateClassProductFirm
2025-09-15Class IIBupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: GravitiGraviti Pharmaceuticals Private Limited
2024-06-24Class IIbuPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per cartonAmerisource Health Services LLC
2023-12-29Class IIbuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for:Rising Pharma Holding, Inc.
2023-11-22Class IIIbuPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun PharSUN PHARMACEUTICAL INDUSTRIES INC
2023-10-04Class IIIBupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by:SUN PHARMACEUTICAL INDUSTRIES INC
2023-05-09Class IIbuPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun PSUN PHARMACEUTICAL INDUSTRIES INC
2022-12-27Class IIBuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: AmericaAmerisource Health Services LLC
2022-04-29Class IIIbuPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: SuSUN PHARMACEUTICAL INDUSTRIES INC
2022-04-29Class IIIbuPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86SUN PHARMACEUTICAL INDUSTRIES INC
2021-03-15Class IIbupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage PhaCardinal Health Inc.
2018-10-05Class IIIContrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Orexigen Therapeutics, Inc.
2018-09-06Class IIIBupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), ManufactureInvaGen Pharmaceuticals, Inc.
2018-08-09Class IIIContrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, DOrexigen Therapeutics, Inc.
2018-03-15Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (InvaGen Pharmaceuticals, Inc.
2018-03-15Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: CiplaInvaGen Pharmaceuticals, Inc.
2016-12-20Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 4733Sun Pharmaceutical Industries, Inc.
2016-11-02Class IIIBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06Zydus Pharmaceuticals USA Inc
2016-09-13Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only,Sun Pharmaceutical Industries, Inc.
2016-08-03Class IIIBuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured Zydus Pharmaceuticals USA Inc
2016-06-27Class IIIbuPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun PharmacSun Pharmaceutical Industries, Inc.
2015-07-17Class IIIbuPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, DiSun Pharma Global Fze
2013-11-15Class IIIBuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) Actavis Inc