FDA Drug Recalls

Recalls / Brands / Ondansetron

Ondansetron

5 FDA drug recalls involving brand “Ondansetron.

DateClassProductFirm
2025-12-30Class IIOndansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), RGlenmark Pharmaceuticals Inc., USA
2019-05-22Class IIIOndansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047Fresenius Kabi USA, LLC
2013-09-24Class IIOndansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake FHospira Inc.
2013-05-20Class IIOndansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-0Hospira, Inc.
2012-09-27Class IIONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP PhaFresenius Kabi USA, LLC