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Fresenius Kabi USA, LLC FDA Recalls
53 recalls on file across drugs, devices, 17 of them Class I and 44 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, Class IAug 10, 2026Presence of particulate matter:An internal investigation at |
| Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or IntravenouClass IAug 4, 2026Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, SClass IIJul 16, 2026Presence of Particulate Matter: Hair was found in products |
| Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-DoseClass IIJul 16, 2026Presence of Particulate Matter: Hair was found in products |
| 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 VClass IIJul 16, 2026Presence of Particulate Matter: Hair was found in product |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, SClass IIJul 16, 2026Presence of Particulate Matter: Hair was found in products |
| Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, SterileClass IIJul 16, 2026Presence of Particulate Matter: Hair was found in products |
| Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696Class IIIMay 14, 2026Failed Impurities/Degradations Specifications |
| Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Class IMay 6, 2026Fresenius Kabi has been made aware via customer complaints t |
| LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Class IMay 6, 2026Potential software anomaly that can cause the pump to report |
| 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, FrClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 ("FresClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 BClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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, BDClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 BClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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, FreseClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 ("FClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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, FreseClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 ("FresClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 mLx10Class IIMar 11, 2026Lack of Assurance of Sterility |
| 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, Class IIMar 11, 2026Lack of Assurance of Sterility |
| 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 UClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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, MClass IIMar 11, 2026Lack of Assurance of Sterility |
| 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 ("FresClass IIMar 11, 2026Lack of Assurance of Sterility |
| The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Class IIFeb 4, 2026Potential for the Cassette Loading Lever to break. |
| Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Class IINov 21, 2025Emphasizing instructions for LVP duration programming locate |
| Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patientsClass INov 14, 2025Software version 5.10.1 and earlier contain anomalies that h |
| Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11Class INov 6, 2025Microbial Contamination of Sterile Products; out of limit re |
| Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Class IINov 3, 2025Downstream Occlusion alarms may occur during procedures usin |
| IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).Class INov 3, 2025Incorrect assembly of specific lot of LVP Primary Administra |
| Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Class IISep 3, 2025Potential issue that can cause the device to register "phant |
| LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.Class IIJun 24, 2025Potential for external cassette leaks |
| LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-Class IIJun 24, 2025Potential for external cassette leaks |
| LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.Class IIJun 24, 2025Potential for external cassette leaks |
| LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.Class IIJun 24, 2025Potential for external cassette leaks |
| IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. IntraClass IMay 12, 2025Mis-assembly error of Blood Products Administrations Sets wh |
| Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviroClass IJan 10, 2025Large Volume Pump Software, version 5.9.2 and earlier has po |
| Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Class IDec 6, 2024Potential pneumatic valve failure that may cause the LVP to |
| Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for iClass IAug 30, 2024The software has anomalies that have the potential to cause |
| LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. fClass IAug 1, 2024A defect may cause an uncontrolled medication flow condition |
| LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.Class IMar 7, 2024Software has anomalies that have the potential to cause unde |
| Ivenix Infusion System (IIS), Large Volume Pump LVP-0004Class INov 29, 2023The device may experience mechanical interference on the Flu |
| LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004Class IIMay 10, 2023Retroactively reported corrections from 2023: 1) A software |
| Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004Class IMar 10, 2023Fluid ingress that can cause a loss of electrical funtion an |
| Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg pClass IINov 22, 2022Subpotent Drug: Testing results below the defined limit for |
| Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg peClass IINov 22, 2022Subpotent Drug: Testing results below the defined limit for |
| Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mClass IINov 22, 2022Subpotent Drug: Testing results below the defined limit for |
| LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004Class IISep 16, 2022Retroactively reported correction from 2022: A software defe |
| Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0Class ISep 8, 2022The display screen may become frozen and unresponsive to use |
| Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. IndicatedClass IIApr 22, 2022Start-up time for the flow rate range greater than 50 ml/hr, |
| Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032Class IMar 4, 2022Presence of particulate matter: particulates composed of car |
| Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDCClass IISep 17, 2021Defective container: Cracked vials leading to lack of steril |
| Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), Class IIJun 25, 2021Low out of specification results for epinephrine assay. |