Baxter Healthcare Corporation Provisional
FDA Flags (14)
Class II RecallFeb 2026
Baxter Healthcare Corporation
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6
Classification: Class II
Class II RecallSep 2025
Baxter Healthcare Corporation
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corpo
Classification: Class II
Class II RecallNov 2024
Baxter Healthcare Corporation
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph
Classification: Class II
Class I RecallSep 2024
Baxter Healthcare Corporation
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl
Classification: Class I
Class II RecallJul 2024
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only
Classification: Class II
Class II RecallFeb 2024
Baxter Healthcare Corporation
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial
Classification: Class II
Class II RecallDec 2023
Baxter Healthcare Corporation
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation
Classification: Class II
Class II RecallOct 2023
Baxter Healthcare Corporation
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured f
Classification: Class II
Class II RecallSep 2023
Baxter Healthcare Corporation
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx O
Classification: Class II
Class II RecallSep 2023
Baxter Healthcare Corporation
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Containe
Classification: Class II
Class III RecallAug 2023
Baxter Healthcare Corporation
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar
Classification: Class III
Class II RecallMay 2023
Baxter Healthcare Corporation
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter He
Classification: Class II
Class II RecallMay 2023
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II
Classification: Class II
Class II RecallAug 2022
Baxter Healthcare Corporation
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous
Classification: Class II