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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

260

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 241–260 of 260 recalls

Baxter Healthcare Corporation: REVACLEAR 300 Dialyzer, Product Code 114745L Revaclea...

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

FDAMay 31, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclea...

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

FDAMay 31, 2019Nationwide• Baxter Healthcare Corporation

Dianeal Low Calcium Dialysis Solution (Baxter) – sterility leak (2019)

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

Class IIModerate

1...11 1213

Page 13 of 13Next

FDA

Jan 2, 2019

Nationwide

• Baxter Healthcare Corporation

Metoprolol Tartrate Injection (Baxter) – pH Specification Failure (2018)

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

Class IIILow

FDAOct 15, 2018Nationwide• Baxter Healthcare Corporation

Levofloxacin Injection (Baxter Healthcare) – Superpotent Drug (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Class IIILow

FDASep 25, 2018Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter) – manufacturing deviation (2018)

cGMP Deviation

Class IIModerate

FDASep 6, 2018Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter Healthcare) – CGMP Deviation (2018)

CGMP Deviations

Class IIModerate

FDAAug 21, 2018MS, TX• Baxter Healthcare Corporation

Levofloxacin Injection 750mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Class IIILow

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

Levofloxacin Injection 250mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Class IIILow

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

Levofloxacin Injection 500mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Class IIILow

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

Nexterone Amiodarone Injection (Baxter) – particulate matter (2017)

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

Class IHigh

FDANov 10, 2017Nationwide• Baxter Healthcare Corporation

Intralipid 20% I.V. Fat Emulsion (Baxter) – Temperature Abuse (2017)

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.

Class IHigh

FDASep 15, 2017Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter) – Leaking Bag Risk (2017)

Lack of Assurance of Sterility: Customer complaints for leaking bags.

Class IIModerate

FDAJul 6, 2017Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter) – Potential Leakage Risk (2017)

Lack of Assurance of Sterility: Bags have the potential to leak.

Class IIModerate

FDAJul 6, 2017Nationwide• Baxter Healthcare Corporation

Dextrose Injection (Baxter) – Potential Leakage Risk (2017)

Lack of Assurance of Sterility: Bags have the potential to leak.

Class IIModerate

FDAJul 6, 2017Nationwide• Baxter Healthcare Corporation

Fluconazole Injection (Baxter Healthcare) – Sterility Leak Risk (2017)

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Class IIModerate

FDAMay 15, 2017Nationwide• Baxter Healthcare Corporation

Milrinone Lactate Injection (Baxter Healthcare) – Sterility Leak Risk (2017)

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Class IIModerate

FDAMay 15, 2017Nationwide• Baxter Healthcare Corporation

Premasol Amino Acid Injection (Baxter Healthcare) – Discoloration (2016)

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Class IIModerate

FDADec 6, 2016Nationwide• Baxter Healthcare Corporation

Fluconazole Injection (Baxter Healthcare) – Sterility Concern (2016)

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Class IIModerate

FDADec 6, 2016Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter) – mold contamination (2015)

Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

Class IIModerate

FDASep 2, 2015Nationwide• Baxter Healthcare Corporation