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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 Completed Historical recordClass II

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.

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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FDA Recall Terminated Historical recordClass II

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

by Baxter Healthcare Corporation

Reason
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.
Published
August 24, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Baxter Healthcare Corporation

Reason
Presence of particulate matter in solution - black and transparent particles
Published
November 18, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Product has the potential to leak.
Published
November 27, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Bags have potential to leak.
Published
July 31, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

by Baxter Healthcare Corporation

Reason
Failed Stability Specifications
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Published
January 16, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by Baxter Healthcare Corporation

Reason
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Published
November 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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.

by Baxter Healthcare Corporation

Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Published
October 3, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31

by Baxter Healthcare Corporation

Reason
cGMP Deviation
Published
September 26, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Published
September 5, 2018
Distribution
TX and MS only

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FDA Recall Terminated Historical recordClass III

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.

by Baxter Healthcare Corporation

Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Published
August 15, 2018
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.