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Fresenius Kabi recalls - full list & free alerts

31 official U.S. recalls involving Fresenius Kabi in the last 12 months, most recently on 2026-09-02.

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Full list (31)

Fresenius Kabi USA, LLC: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, I
DrugsFDA (drug) · 2026-09-02 · Class I
Fresenius Kabi USA, LLC: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fres
DrugsFDA (drug) · 2026-08-26 · Class I
Fresenius Kabi USA, LLC: 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
DrugsFDA (drug) · 2026-07-29 · Class II
Fresenius Kabi USA, LLC: 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
DrugsFDA (drug) · 2026-07-29 · Class II
Fresenius Kabi USA, LLC: 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, Fre
DrugsFDA (drug) · 2026-07-29 · Class II
Fresenius Kabi USA, LLC: 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
DrugsFDA (drug) · 2026-07-29 · Class II
Fresenius Kabi USA, LLC: 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
DrugsFDA (drug) · 2026-07-29 · Class II
Fresenius Kabi USA, LLC: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 6332
DrugsFDA (drug) · 2026-06-17 · Class III
Fresenius Kabi USA, LLC: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Medical DevicesFDA (device) · 2026-06-10 · Class I
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Medical DevicesFDA (device) · 2026-06-10 · Class I
Fresenius Kabi USA, LLC: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Medical DevicesFDA (device) · 2026-06-10 · Class II
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 USA,
DrugsFDA (drug) · 2026-04-15 · Class II
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"), Lake Z
DrugsFDA (drug) · 2026-04-15 · Class II
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, LL
DrugsFDA (drug) · 2026-04-15 · Class II
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, LLC (
DrugsFDA (drug) · 2026-04-15 · Class II
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, LLC (
DrugsFDA (drug) · 2026-04-15 · Class II
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 by B
DrugsFDA (drug) · 2026-04-15 · Class II
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 and
DrugsFDA (drug) · 2026-04-15 · Class II
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 and C
DrugsFDA (drug) · 2026-04-15 · Class II
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: Fre
DrugsFDA (drug) · 2026-04-15 · Class II
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 Medical
DrugsFDA (drug) · 2026-04-15 · Class II
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 and
DrugsFDA (drug) · 2026-04-15 · Class II
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"), Unit o
DrugsFDA (drug) · 2026-04-15 · Class II
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"), Unit o
DrugsFDA (drug) · 2026-04-15 · Class II
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"), Uni
DrugsFDA (drug) · 2026-04-15 · Class II
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Medical DevicesFDA (device) · 2026-01-21 · Class II
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Medical DevicesFDA (device) · 2025-12-24 · Class I
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 Infusi
Medical DevicesFDA (device) · 2025-12-10 · Class I
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical DevicesFDA (device) · 2025-12-10 · Class II
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), 6332
DrugsFDA (drug) · 2025-12-03 · Class I
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical DevicesFDA (device) · 2025-11-05 · Class II