Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: 9 recalls listed since January 2026 across FDA; 4 rated high risk.

By year

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, swelling, vein inflammation, blood clots, and organ damage.

High riskFDAAug 10, 2026Foreign object

Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

High riskFDAAug 4, 2026Labeling error

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections contain particulate matter.

Moderate riskFDAJul 23, 2026Foreign object

Epinephrine Injection failed impurities and degradations specifications.

Low riskFDAJun 5, 2026Drug impurity

The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.

High riskFDAJun 3, 2026Software defect

The Ivenix Large Volume Pump can be damaged by dropping or jarring, causing unintended touchscreen behavior.

High riskFDAMay 29, 2026Device defect

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) has a cassette loading lever that can break.

Moderate riskFDAMay 29, 2026Device defect

Sodium chloride and dextrose injections lack assurance of sterility.

Moderate riskFDAApr 3, 2026Sterility problem

The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.

Moderate riskFDAJan 12, 2026Software defect