FDA Drug Recalls

Recalls / Active ingredient / Water

Water

10 FDA drug recalls involving the active ingredient “Water2 Class I.

DateClassProductFirm
2025-12-22Class IISterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation DeerfBaxter Healthcare Corporation
2025-08-26Class IISTERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60B BRAUN MEDICAL INC
2024-03-29Class IIEyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian EHONEYWELL INC
2023-02-23Class IISterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Nephron Sc Inc
2023-01-12Class IISterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL SingNephron Sc Inc
2022-04-13Class IISterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06Mckesson Medical-Surgical Inc. Corporate Office
2021-05-03Class IISterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, DisPfizer Inc.
2021-03-22Class INovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, RNovo Nordisk Inc
2021-03-22Class INovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Novo Nordisk Inc
2019-09-06Class IIBacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 Pfizer Inc.