Fresenius Kabi Usa recalls
Fresenius Kabi Usa appears in 95 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
FDA Drug · Class I · 2026-09-02 · Fresenius Kabi Usa - Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - 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 Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fr…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - 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, Fresenius Kabi, La…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 633…
FDA Drug · Class III · 2026-06-17 · Fresenius Kabi Usa - LVP software of the Ivenix Infusion System (IIS)
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa - The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004
FDA Device · Class II · 2026-06-10 · Fresenius Kabi Usa - 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, LLC…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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 Medical…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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"), Lake…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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"), Unit…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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 USA,…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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 an…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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 and…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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 and…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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, L…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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, LLC…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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"), Un…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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"), Unit…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - 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: Fr…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
FDA Device · Class II · 2026-01-21 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-12-24 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-12-10 · Fresenius Kabi Usa - IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class I · 2025-12-10 · Fresenius Kabi Usa - 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), 633…
FDA Drug · Class I · 2025-12-03 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-11-05 · Fresenius Kabi Usa - LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administra…
FDA Device · Class I · 2025-06-18 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-02-12 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2025-01-15 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), LVP Software
FDA Device · Class I · 2024-10-02 · Fresenius Kabi Usa - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infu…
FDA Device · Class I · 2024-09-11 · Fresenius Kabi Usa - LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0
FDA Device · Class I · 2024-04-17 · Fresenius Kabi Usa - LVP software of the Ivenix Infusion System (IIS)
FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa - LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
FDA Device · Class I · 2023-12-27 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004
FDA Device · Class II · 2023-10-04 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Device · Class I · 2023-04-19 · Fresenius Kabi Usa - Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg pe…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per m…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa - Ivenix Infusion System (IIS), LVP Software
FDA Device · Class I · 2022-10-12 · Fresenius Kabi Usa