Fresenius Kabi
33 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fresenius Kabi and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-08-04FDA-PRFresenius Kabi Morphine syringes recalled for wrong opioid in packaging
FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syri
- 2026-07-29FDA-DrugClass IIFresenius Kabi Xylocaine recalled for particulate matter contamination
Presence of Particulate Matter: Hair was found in products
- 2026-07-29FDA-DrugClass IIFresenius Kabi Xylocaine injection recalled for particulate contamination
Presence of Particulate Matter: Hair was found in products
- 2026-07-29FDA-DrugClass IIFresenius Kabi Naropin recalled for particulate matter
Presence of Particulate Matter: Hair was found in products
- 2026-07-29FDA-DrugClass IIFresenius Kabi lidocaine injection recalled for hair contamination
Presence of Particulate Matter: Hair was found in products
- 2026-07-29FDA-DrugClass IIFresenius Kabi glycopyrrolate injection recalled for particulate contamination
Presence of Particulate Matter: Hair was found in product
- 2026-06-17FDA-DrugClass IIIFresenius Kabi epinephrine injection recalled for impurity concerns
Failed Impurities/Degradations Specifications
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi dextrose injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIDo not use Fresenius Kabi dextrose injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi dextrose injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi sodium chloride injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass II0.9% 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 Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIDo not use Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi sodium chloride injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-04-15FDA-DrugClass IIStop using Fresenius Kabi saline injection
Lack of Assurance of Sterility
- 2026-02-18FDA-DrugClass IIStop using recalled Fresenius Kabi vancomycin injection
Lack of Assurance of Sterility
- 2026-02-18FDA-DrugClass IIStop using Fresenius Kabi vancomycin HCl IV bags
Lack of Assurance of Sterility
- 2026-02-18FDA-DrugClass IIDo not use Fresenius Kabi thiamine HCl injection
Lack of Assurance of Sterility
- 2026-02-18FDA-DrugClass IIDo not use Fresenius Kabi ketamine HCl injection
Lack of Assurance of Sterility
- 2026-02-18FDA-DrugClass IIDo not use Fresenius Kabi acyclovir sodium IV bags
Lack of Assurance of Sterility
- 2026-01-21FDA-DeviceClass IICheck Fresenius Kabi Ivenix Infusion System software
Emphasizing instructions for LVP duration programming located in the IFU.
- 2025-12-24FDA-DeviceClass IUpdate Ivenix Infusion System software immediately
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- 2025-12-10FDA-DeviceClass IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- 2025-12-10FDA-DeviceClass IIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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