thejoe Baxter Healthcare Corporation

Baxter Healthcare Corporation: 36 FDA recall reports

Every drug recall the FDA has published for Baxter Healthcare Corporation. The fault, and how the agency graded it.

36Reports

3Class I

6Ongoing

2026-02-04Most recent

3 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	27
Class III	6
Class I	3

By year reported

Year	Reports
2015	1
2016	1
2017	7
2018	8
2019	4
2020	1
2022	1
2023	7
2024	4
2025	1
2026	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerf

D-0296-2026 · Class II · reported 2026-02-04 · Ongoing

Why it was recalled: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Product: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Where it went: Nationwide
How much: 125,496 bottles

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Health

D-0596-2025 · Class II · reported 2025-09-03 · Ongoing

Why it was recalled: Discoloration
Product: 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.
Where it went: U.S.A. Nationwide
How much: 13,000 containers

Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by:

D-0039-2025 · Class II · reported 2024-11-13 · Ongoing

Why it was recalled: Labeling: Missing Label
Product: 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
Where it went: Nationwide within the USA
How much: 60,594 units

Class I

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Ste

D-0649-2024 · Class I · reported 2024-09-11 · Ongoing

Why it was recalled: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Product: 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
Where it went: Nationwide in the USA
How much: 44,208 containers

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administr

D-0587-2024 · Class II · reported 2024-07-17 · Ongoing

Why it was recalled: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Product: 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
Where it went: US Nationwide, Canada
How much: 6,874 bags

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 2

D-0336-2024 · Class II · reported 2024-02-28 · Ongoing

Why it was recalled: 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.
Product: 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
Where it went: Nationwide in the USA
How much: 13,000 bags

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare C

D-0146-2024 · Class II · reported 2023-12-13 · Completed

Why it was recalled: Failed pH Specifications
Product: 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
Where it went: Nationwide in the USA
How much: 6,022,675 vials

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manu

D-0048-2024 · Class II · reported 2023-10-25 · Terminated

Why it was recalled: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Product: 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
Where it went: Nationwide in the USA
How much: 472 vials

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull

D-1141-2023 · Class II · reported 2023-09-06 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product: 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
Where it went: Nationwide in the USA
How much: 22,112 bags

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX I

D-1140-2023 · Class II · reported 2023-09-06 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product: 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.
Where it went: Nationwide in the USA
How much: a) 44,520; b) 60,762; c) 483,912

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter

D-1103-2023 · Class III · reported 2023-08-30 · Completed

Why it was recalled: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Product: 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.
Where it went: Nationwide in the U.S.A.
How much: 13,502 vials

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only,

D-0543-2023 · Class II · reported 2023-05-03 · Completed

Why it was recalled: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product: 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.
Where it went: Nationwide in the USA
How much: 9,788 bags

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Am

D-0542-2023 · Class II · reported 2023-05-03 · Completed

Why it was recalled: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product: Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Where it went: Nationwide in the USA
How much: a) 95,448 bags; b) 174,522 bags

Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For In

D-1348-2022 · Class II · reported 2022-08-24 · Terminated

Why it was recalled: Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Product: Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Where it went: Nationwide in the USA
How much: 85,680 bags

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose amp

D-0076-2021 · Class II · reported 2020-11-18 · Terminated

Why it was recalled: Presence of particulate matter in solution - black and transparent particles
Product: Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10
Where it went: Nationwide USA

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015,

D-0517-2020 · Class II · reported 2019-11-27 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product has the potential to leak.
Product: 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Where it went: Nationwide within the United States
How much: 22336 bags

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfiel

D-1514-2019 · Class II · reported 2019-07-31 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Bags have potential to leak.
Product: 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Where it went: Nationwide in the United States and Puerto Rico.
How much: 139,680 Containers

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation

D-1435-2019 · Class II · reported 2019-06-19 · Terminated

Why it was recalled: Failed Stability Specifications
Product: Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Where it went: Nationwide within the United States
How much: 5940 bottles

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container ba

D-0351-2019 · Class II · reported 2019-01-16 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Where it went: Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
How much: 29,370 bags

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Man

D-0222-2019 · Class III · reported 2018-11-14 · Terminated

Why it was recalled: Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Product: Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
Where it went: Distributed nationwide in the USA and Puerto Rico
How much: 402,165 vials

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-

D-1215-2018 · Class III · reported 2018-10-03 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
Where it went: Nationwide USA and Puerto Rico
How much: 523,896 bags

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -

D-1190-2018 · Class II · reported 2018-09-26 · Terminated

Why it was recalled: cGMP Deviation
Product: 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Where it went: Nationwide.
How much: 5184 bags

0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA

D-1128-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: CGMP Deviations
Product: 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Where it went: TX and MS only
How much: 33600 bags

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Contain

D-1034-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Where it went: Nationwide USA and Puerto Rico
How much: 191,256 bags

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Conta

D-1036-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Where it went: Nationwide USA and Puerto Rico
How much: 711,216 bags

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Conta

D-1035-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Where it went: Nationwide USA and Puerto Rico
How much: 106,320 bags

Class I

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare C

D-0573-2018 · Class I · reported 2018-02-07 · Terminated

Why it was recalled: Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Product: Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Where it went: Nationwide within USA and Puerto Rico
How much: 35,628 single-dose containers

Class I

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden

D-0030-2018 · Class I · reported 2017-11-01 · Terminated

Why it was recalled: Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Product: Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58
Where it went: Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
How much: 910 bags

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deer

D-0957-2017 · Class II · reported 2017-07-19 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Customer complaints for leaking bags.
Product: 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
Where it went: Nationwide in USA
How much: 131,904 bags

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfie

D-0972-2017 · Class II · reported 2017-07-19 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Bags have the potential to leak.
Product: 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38
Where it went: Nationwide, Puerto Rico and Saudi Arabia
How much: 54,528 bags

Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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