Brand

Fresenius Kabi Usa, Llc Recalls

81 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fresenius Kabi Usa, Llc.

81Total Recalls
22Critical
45.3MUnits Affected
Mar 11, 2026Most Recent
All Recalls

Every Fresenius Kabi Usa, Llc Recall

Sorted by most recent. Click any recall for full details.

81 recalls
High RiskFDA
Fresenius Kabi Usa, Llc
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, Fresenius Kabi USA, LL...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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, Fresenius Kabi US...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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, Manufactured for: ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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, Fresenius Kabi USA,...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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, Fresenius Kabi USA, LL...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 Beckton, Dickson a...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 ("Fresenius Kabi"), Uni...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 ("Fresenius Kabi"), ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 ("Fresenius Kabi"), Uni...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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, Fresenius Medic...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 ("Fresenius Kabi"), Lak...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed b...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 Becton, Dickson an...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
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 Becton, Dickson ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Medical Devices·30 affected·Nov 21, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Medical Devices·30 affected·Nov 14, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
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 (unit of use), 6...
Injectable Drugs·2,199,850 affected·Nov 6, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices·15,862 affected·Nov 3, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Inf...
Medical Devices·483 affected·Nov 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices·6 affected·Sep 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Medical Devices·348,150 affected·Jun 24, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Medical Devices·19,225 affected·Jun 24, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administ...
Medical Devices·14,280 affected·May 12, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the co...
Medical Devices·23 affected·Jan 10, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Medical Devices·1,520 affected·Dec 6, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion managemen...
Medical Devices·17 affected·Aug 30, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous in...
Medical Devices·180 affected·Aug 1, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Medical Devices·17 affected·Mar 7, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Medical Devices·938 affected·Nov 29, 2023
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Medical Devices·6 affected·May 10, 2023
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Medical Devices·1,546 affected·Mar 10, 2023
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per...
Injectable Drugs·40,025 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 ...
Injectable Drugs·31,600 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg ...
Injectable Drugs·40,375 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Medical Devices·3 affected·Sep 16, 2022
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Medical Devices·4 affected·Sep 8, 2022
CriticalFDA
Fresenius Kabi Usa, Llc
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: ...
Injectable Drugs·118,040 affected·Mar 4, 2022
High RiskFDA
Fresenius Kabi Usa Llc
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 2...
Injectable Drugs·963,000 affected·Sep 17, 2021
High RiskFDA
Fresenius Kabi Usa Llc
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose...
Injectable Drugs·234,800 affected·Jun 25, 2021
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·945,425 affected·Dec 23, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zu...
Injectable Drugs·490,633 affected·Dec 17, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323...
Injectable Drugs·4,411 affected·Dec 10, 2020
RecallFDA
Fresenius Kabi Usa, Llc
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Freseni...
Injectable Drugs·16,986 affected·Nov 17, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, L...
Injectable Drugs·13,525 affected·Nov 17, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 ...
Injectable Drugs·25,100 affected·Jul 22, 2020
RecallFDA
Fresenius Kabi Usa, Llc
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Injectable Drugs·63,067 affected·Jul 13, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·5,314,400 affected·Apr 20, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Si...
Injectable Drugs·3,497,575 affected·Apr 20, 2020