Fresh Recalls

Fresenius Kabi USA recalls

11 recent recalls on record for Fresenius Kabi USA in connected official government data as of October 22, 2026 at 6:00 PM UTC.

Models with recalls

Epinephrine Injection (1)Glycopyrrolate Injection (1)Ivenix Infusion System (IIS) (1)LVP software of the Ivenix Infusion System (IIS) (1)Lidocaine HCl Injection (1)Morphine Sulfate Injection (1)Naropin (ropivacaine hydrochloride Injection (1)The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) (1)Tyenne (tocilizumab-aazg) Injection (1)Xylocaine (lidocaine HCl Injection (2)

All Fresenius Kabi USA recalls

FDA Class I · Drug · September 2, 2026

Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLC

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Official ID D-0827-2026 · Official record ↗

FDA Class I · Drug · August 26, 2026

Morphine Sulfate Injection recall — Fresenius Kabi USA, LLC

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

Official ID D-0788-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Official ID D-0729-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Official ID D-0728-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Naropin (ropivacaine hydrochloride Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Official ID D-0727-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Official ID D-0726-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Glycopyrrolate Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in product

Official ID D-0725-2026 · Official record ↗

FDA Class III · Drug · June 17, 2026

Epinephrine Injection recall — Fresenius Kabi USA, LLC

Failed Impurities/Degradations Specifications

Official ID D-0581-2026 · Official record ↗

FDA Class II · Medical device · June 10, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Potential for the Cassette Loading Lever to break.

Official ID Z-2274-2026 · Official record ↗

FDA Class I · Medical device · June 10, 2026

Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or rea…

Official ID Z-2224-2026 · Official record ↗

FDA Class I · Medical device · June 10, 2026

LVP software of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless …

Official ID Z-2223-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.