Recalls / Firms / Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc

92 FDA drug recalls on record — 3 Class I.

Date	Class	Drug	Status
2026-03-09	Class II	Icosapent Ethyl	Ongoing
2025-12-30	Class II	Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Hea	Ongoing
2025-12-19	Class III	Trazodone Hydrochloride	Ongoing
2025-10-23	Class II	Bromocriptine Mesylate	Ongoing
2025-10-22	Class II	Clomipramine Hydrochloride	Ongoing
2025-10-22	Class II	Clomipramine Hydrochloride	Ongoing
2025-10-22	Class II	Clomipramine Hydrochloride	Ongoing
2025-09-24	Class II	Entecavir	Ongoing
2025-09-24	Class II	Entecavir	Ongoing
2025-09-04	Class II	Entecavir	Ongoing
2025-09-04	Class II	Entecavir	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-09-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-08-27	Class II	Succinylcholine Chloride	Ongoing
2025-05-30	Class II	Icosapent Ethyl	Ongoing
2025-05-13	Class II	Esomeprazole Magnesium	Ongoing
2025-05-13	Class II	Esomeprazole Magnesium	Ongoing
2025-04-03	Class II	Chlorpromazine Hydrochloride	Ongoing
2025-03-21	Class II	Venlafaxine	Ongoing
2025-02-13	Class II	Nelarabine	Ongoing
2025-02-13	Class II	Nelarabine	Ongoing
2024-11-14	Class III	Esomeprazole Magnesium	Ongoing
2024-07-02	Class III	Verapamil Hydrochloride	Ongoing
2024-07-02	Class III	Verapamil Hydrochloride	Ongoing
2024-07-02	Class III	Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zy	Completed
2024-07-02	Class III	Micafungin	Completed
2024-06-27	Class II	Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured	Terminated
2024-06-21	Class II	Venlafaxine Hydrochloride	Terminated
2024-05-16	Class III	Estradiol	Ongoing
2024-05-16	Class III	Estradiol	Ongoing
2023-10-19	Class II	Oxybutynin	Completed
2023-10-19	Class II	Oxybutynin	Completed
2023-10-19	Class II	Oxybutynin	Completed
2023-09-21	Class II	Oxybutynin	Terminated
2023-02-24	Class III	Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 1	Terminated
2022-07-15	Class II	Fulvestrant	Terminated
2021-08-13	Class II	Carvedilol	Terminated
2021-02-18	Class I	Acyclovir	Terminated
2021-02-18	Class I	Acyclovir	Terminated
2020-12-03	Class II	Lansoprazole	Terminated
2020-12-03	Class II	Lansoprazole	Terminated
2020-10-27	Class II	Lansoprazole	Terminated
2020-10-27	Class II	Lansoprazole	Terminated
2020-01-31	Class II	Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured	Terminated
2019-05-06	Class II	Methylprednisolone	Terminated
2019-05-06	Class II	Anastrozole	Terminated
2019-05-06	Class II	Anastrozole	Terminated
2019-05-06	Class II	Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cad	Terminated
2019-05-06	Class II	Methylprednisolone	Terminated
2019-05-06	Class II	Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Ca	Terminated
2019-05-06	Class II	Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cad	Terminated
2019-05-06	Class II	Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadil	Terminated
2019-05-06	Class II	Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by:	Terminated
2019-05-06	Class II	Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by	Terminated
2019-05-06	Class II	Methylprednisolone	Terminated
2019-05-06	Class II	Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadil	Terminated
2019-05-06	Class II	Methylprednisolone	Terminated
2019-05-06	Class II	Methylprednisolone	Terminated
2019-04-25	Class II	Acyclovir	Terminated
2019-04-25	Class II	Carvedilol	Terminated
2019-04-22	Class III	Carvedilol	Terminated
2017-11-20	Class II	Paroxetine	Terminated
2017-08-18	Class II	Paroxetine	Terminated
2017-05-10	Class II	Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-03	Terminated
2017-05-10	Class II	Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufac	Terminated
2017-05-10	Class II	Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01)	Terminated
2017-03-15	Class II	Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) a	Terminated
2017-03-06	Class II	Atenolol	Terminated
2016-11-02	Class III	Bupropion	Terminated
2016-08-03	Class III	Bupropion	Terminated
2016-07-19	Class II	Venlafaxine Hydrochloride	Terminated
2016-07-19	Class II	Venlafaxine Hydrochloride	Terminated
2016-05-09	Class II	Bromocriptine Mesylate	Terminated
2016-01-14	Class III	risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by:	Terminated
2014-12-23	Class II	Benzonatate	Terminated
2014-11-26	Class II	Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Hea	Terminated
2014-10-01	Class III	Amlodipine Besylate	Terminated
2014-09-24	Class III	BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila H	Terminated
2014-09-15	Class II	Topiramate	Terminated
2014-08-05	Class II	Atenolol	Terminated
2014-05-08	Class II	Promethazine Hydrochloride	Terminated
2013-05-13	Class I	Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Ca	Terminated
2013-03-05	Class II	Venlafaxine	Terminated
2012-03-14	Class II	Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Ma	Terminated