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Baxter Healthcare Corporation

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20151
20161
20177
20188
20194
20201
20221
20237
20244
20251
20261
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FDA Recall Ongoing 2026 recordClass II

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

by Baxter Healthcare Corporation

Reason
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Published
February 4, 2026
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

by Baxter Healthcare Corporation

Reason
Discoloration
Published
September 3, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01

by Baxter Healthcare Corporation

Reason
Labeling: Missing Label
Published
November 13, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

by Baxter Healthcare Corporation

Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Published
September 11, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Published
July 17, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20

by Baxter Healthcare Corporation

Reason
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Published
February 28, 2024
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

by Baxter Healthcare Corporation

Reason
Failed pH Specifications
Published
December 13, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

by Baxter Healthcare Corporation

Reason
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Published
October 25, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Published
September 6, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Published
September 6, 2023
Distribution
Nationwide

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FDA Recall Completed Historical recordClass III

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

by Baxter Healthcare Corporation

Reason
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Published
August 30, 2023
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Published
May 3, 2023
Distribution
Nationwide

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This page lists recalls that name Baxter Healthcare Corporation as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.