Recalls / Active ingredient / Ondansetron Hydrochloride

Ondansetron Hydrochloride

7 FDA drug recalls involving the active ingredient “Ondansetron Hydrochloride”.

Date	Class	Product	Firm
2025-12-30	Class II	Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), R	Glenmark Pharmaceuticals Inc., USA
2023-11-14	Class II	Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare C	Baxter Healthcare Corporation
2022-04-13	Class II	Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30	Mckesson Medical-Surgical Inc. Corporate Office
2019-05-22	Class III	Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047	Fresenius Kabi USA, LLC
2013-09-24	Class II	Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake F	Hospira Inc.
2013-05-20	Class II	Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-0	Hospira, Inc.
2012-09-27	Class II	ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pha	Fresenius Kabi USA, LLC