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Baxter Healthcare Corp.

Baxter Healthcare Corp. Recalls

All product recalls associated with Baxter Healthcare Corp..

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Recall Summary

Total Recalls

467

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 301–320 of 467 recalls

Brevibloc (Baxter) – Particle Contamination (2014)

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Class IIModerate

FDAJun 16, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes

Class IHigh

FDAMay 12, 2014Nationwide• Baxter Healthcare Corp.

Famotidine Injection (Baxter) – Particulate Matter (2014)

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

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Class IIModerate

FDAApr 24, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Irrigation (Baxter) – particulate nylon fibers (2014)

Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.

Class IIModerate

FDAApr 21, 2014Nationwide• Baxter Healthcare Corp.

Dianeal PD-2 Dialysis Solution (Baxter) – Non-Sterility Risk (2014)

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Class IHigh

FDAFeb 11, 2014Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Particulate Matter Risk (2013)

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Class IHigh

FDANov 21, 2013Nationwide• Baxter Healthcare Corp.

Dextrose Injection (Baxter) – Particulate Matter Risk (2013)

Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Class IHigh

FDANov 21, 2013Nationwide• Baxter Healthcare Corp.

Clinimix E 4.25/10 Injection (Baxter) – Particulate Matter Risk (2013)

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Class IHigh

FDANov 18, 2013Nationwide• Baxter Healthcare Corp.

Clinimix 5/15 (Baxter) – Particulate Matter (2013)

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Class IHigh

FDANov 18, 2013Nationwide• Baxter Healthcare Corp.

Nitroglycerin Injection (Baxter) – Particulate Matter Risk (2013)

Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

Class IHigh

FDANov 18, 2013Nationwide• Baxter Healthcare Corp.

Clinimix 4.25/25 Injection (Baxter) – Particulate Matter Risk (2013)

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Class IHigh

FDANov 18, 2013Nationwide• Baxter Healthcare Corp.

Travasol Injection (Baxter) – Sterility Risk (2013)

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

Class IIModerate

FDANov 12, 2013Nationwide• Baxter Healthcare Corp.

DIANEAL Low Calcium (Baxter) – Potential Leak Risk (2013)

Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Class IIModerate

FDAJul 24, 2013Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – sterility port leakage (2013)

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Class IIModerate

FDAMay 21, 2013Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – sterility port leakage (2013)

Class IIModerate

FDAMay 21, 2013Nationwide• Baxter Healthcare Corp.

Lidocaine Hydrochloride Dextrose Injection (Baxter) – sterility port leakage (2013)

Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Class IIModerate

FDAMay 21, 2013Nationwide• Baxter Healthcare Corp.

Sodium Chloride Injection (Baxter) – Wrong Barcode (2013)

Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

Class IIModerate

FDAFeb 27, 2013Nationwide• Baxter Healthcare Corp.

Stay Informed

Baxter Healthcare Corp. Recalls

Recall Summary

Brevibloc (Baxter) – Particle Contamination (2014)

Sodium Chloride Injection (Baxter) – Particulate Contamination (2014)

Famotidine Injection (Baxter) – Particulate Matter (2014)

Sodium Chloride Irrigation (Baxter) – particulate nylon fibers (2014)

Dianeal PD-2 Dialysis Solution (Baxter) – Non-Sterility Risk (2014)

Sodium Chloride Injection (Baxter) – Particulate Matter Risk (2013)

Dextrose Injection (Baxter) – Particulate Matter Risk (2013)

Clinimix E 4.25/10 Injection (Baxter) – Particulate Matter Risk (2013)

Clinimix 5/15 (Baxter) – Particulate Matter (2013)

Nitroglycerin Injection (Baxter) – Particulate Matter Risk (2013)

Clinimix 4.25/25 Injection (Baxter) – Particulate Matter Risk (2013)

Travasol Injection (Baxter) – Sterility Risk (2013)

DIANEAL Low Calcium (Baxter) – Potential Leak Risk (2013)

Sodium Chloride Injection (Baxter) – sterility port leakage (2013)

Sodium Chloride Injection (Baxter) – sterility port leakage (2013)

Lidocaine Hydrochloride Dextrose Injection (Baxter) – sterility port leakage (2013)

Metronidazole Injection (Baxter) – sterility port leakage (2013)

5% Dextrose Injection (Baxter) – sterility port leakage (2013)

Heparin Sodium Injection (Baxter) – sterility port leakage (2013)

Sodium Chloride Injection (Baxter) – Wrong Barcode (2013)