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Fresenius Kabi USA Recalls
93 recalls on record · July 17, 2013 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, S
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, S
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose V
Hazard: Presence of Particulate Matter: Hair was found in product
June 17, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696
Hazard: Failed Impurities/Degradations Specifications
June 10, 2026Medical DevicesFDA
Fresenius Kabi USA, LLC recalls The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Hazard: Potential for the Cassette Loading Lever to break.
June 10, 2026Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Hazard: 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 readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
June 10, 2026Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Hazard: 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 it is reconnected to AC mains power.
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("F
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, M
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD B
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD B
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Frese
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Frese
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fr
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only,
Hazard: Lack of Assurance of Sterility
January 21, 2026Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Hazard: Emphasizing instructions for LVP duration programming located in the IFU.
December 24, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients
Hazard: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
December 10, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Hazard: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
December 10, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).
Hazard: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
December 3, 2025DrugsFDA
Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11
Hazard: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
November 5, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Hazard: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
August 6, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-
Hazard: Potential for external cassette leaks