Lake Zurich, IL, United States
Fresenius Kabi USA, LLC recalls
44 recalls recorded since 2018, most recently on 10 August 2026. 24 are listed as ongoing. Status and classification are as published by the FDA.
Recalls44
Ongoing (FDA)24
Terminated or completed20
Class I (FDA)24
Ongoing Class I Drugs
- Recall started
- 10 August 2026
- Reason
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0827-2026
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Ongoing Class I Drugs
- Recall started
- 4 August 2026
- Reason
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Distribution
- Nationwide within the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0788-2026
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale N
Ongoing Class II Drugs
- Recall started
- 16 July 2026
- Reason
- Presence of Particulate Matter: Hair was found in products
- Distribution
- Nationwide within in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0727-2026, D-0728-2026, D-0726-2026, D-0729-2026, D-0725-2026
- 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, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-
- 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 Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
- 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, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
- 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 Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
- 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, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Ongoing Class III Drugs
- Recall started
- 14 May 2026
- Reason
- Failed Impurities/Degradations Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0581-2026
- Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Ongoing Class I Medical devices
- Recall started
- 6 May 2026
- Reason
- Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2223-2026
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Ongoing Class I Medical devices
- Recall started
- 6 May 2026
- Reason
- Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- Distribution
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2224-2026
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Ongoing Class II Drugs
- Recall started
- 11 March 2026
- Reason
- Lack of Assurance of Sterility
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0427-2026, D-0424-2026, D-0432-2026, D-0426-2026, D-0428-2026, D-0430-2026, D-0435-2026, D-0437-2026, D-0436-2026, D-0433-2026, D-0425-2026, D-0429-2026 and 2 more
- 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 ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of
- 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, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Un
- 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: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20
- 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, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Uni
- 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 ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of
- 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 Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manuf
- 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 of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
- 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"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 4 February 2026
- Reason
- Potential for the Cassette Loading Lever to break.
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2274-2026
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Ongoing Class II Medical devices
- Recall started
- 21 November 2025
- Reason
- Emphasizing instructions for LVP duration programming located in the IFU.
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1048-2026
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Ongoing Class I Medical devices
- Recall started
- 14 November 2025
- Reason
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0885-2026
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Ongoing Class I Drugs
- Recall started
- 6 November 2025
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0182-2026
- 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), 63323-739-12 (unit of sale).
Ongoing Class II Medical devices
- Recall started
- 3 November 2025
- Reason
- Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- Distribution
- US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0848-2026
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Ongoing Class I Medical devices
- Recall started
- 3 November 2025
- Reason
- Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0586-2026
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Ongoing Class II Medical devices
- Recall started
- 3 September 2025
- Reason
- Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Distribution
- US Nationwide distribution in the state of Minnesota.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0378-2026
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Ongoing Class II Medical devices
- Recall started
- 24 June 2025
- Reason
- Potential for external cassette leaks
- Distribution
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2235-2025, Z-2232-2025, Z-2234-2025, Z-2233-2025
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
- LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Ongoing Class I Medical devices
- Recall started
- 12 May 2025
- Reason
- Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
- Distribution
- US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1869-2025
- IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Ongoing Class I Medical devices
- Recall started
- 10 January 2025
- Reason
- Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
- Distribution
- US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1019-2025
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administrat
Ongoing Class I Medical devices
- Recall started
- 6 December 2024
- Reason
- Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
- Distribution
- US distribution to states of: ID, MN, NV, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0763-2025
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Ongoing Class I Medical devices
- Recall started
- 30 August 2024
- Reason
- The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3153-2024
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Ongoing Class I Medical devices
- Recall started
- 1 August 2024
- Reason
- A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
- Distribution
- US Distribution to states of: CO, ID, NJ, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2721-2024
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Ongoing Class I Medical devices
- Recall started
- 7 March 2024
- Reason
- Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- Distribution
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1484-2024
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Ongoing Class I Medical devices
- Recall started
- 29 November 2023
- Reason
- The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
- Distribution
- US distribution to states of: CA, CO, NJ, UT, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0549-2024
- Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Completed Class II Medical devices
- Recall started
- 10 May 2023
- Reason
- Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Distribution
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1283-2024
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Ongoing Class I Medical devices
- Recall started
- 10 March 2023
- Reason
- Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
- Distribution
- Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1313-2023
- Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Terminated Class II Drugs
- Recall started
- 22 November 2022
- Terminated
- 23 October 2023
- Reason
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0128-2023, D-0129-2023, D-0127-2023
- Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Via
- 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 per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose V
- Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose
Completed Class II Medical devices
- Recall started
- 16 September 2022
- Reason
- Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
- Distribution
- US Nationwide distribution in the states of WI and NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1282-2024
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Terminated Class I Medical devices
- Recall started
- 8 September 2022
- Terminated
- 10 September 2024
- Reason
- The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
- Distribution
- Domestic distribution to NJ and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0002-2023
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Ongoing Class II Medical devices
- Recall started
- 22 April 2022
- Reason
- Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
- Distribution
- US Nationwide distribution in the states of NJ, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2635-2023
- Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of flui
Terminated Class I Drugs
- Recall started
- 4 March 2022
- Terminated
- 29 September 2023
- Reason
- Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0750-2022
- 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: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zuri
Terminated Class II Drugs
- Recall started
- 17 September 2021
- Terminated
- 20 June 2023
- Reason
- Defective container: Cracked vials leading to lack of sterility assurance
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0856-2021
- 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. 25 vials per tray packaged 18 trays per shipper
Terminated Class II Drugs
- Recall started
- 25 June 2021
- Terminated
- 28 December 2022
- Reason
- Low out of specification results for epinephrine assay.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0651-2021
- 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 Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047.
Terminated Class I Drugs
- Recall started
- 23 December 2020
- Terminated
- 9 June 2023
- Reason
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0245-2021
- 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 per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich,
Terminated Class II Drugs
- Recall started
- 17 December 2020
- Terminated
- 20 June 2023
- Reason
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Distribution
- USA Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0184-2021
- 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 Zurich, IL 60047, NDC 63323-162-02
Terminated Class II Drugs
- Recall started
- 10 December 2020
- Terminated
- 25 August 2022
- Reason
- Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0172-2021
- 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 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fr
Terminated Class III Drugs
- Recall started
- 17 November 2020
- Terminated
- 25 August 2022
- Reason
- Cross Contamination with Other Products: trace amounts of octreotide found during testing
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0105-2021
- 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, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
Terminated Class I Drugs
- Recall started
- 17 November 2020
- Terminated
- 12 September 2022
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0120-2021
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
Terminated Class I Drugs
- Recall started
- 22 July 2020
- Terminated
- 12 September 2022
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1537-2020
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671
Terminated Class III Drugs
- Recall started
- 13 July 2020
- Terminated
- 19 August 2022
- Reason
- Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1391-2020
- 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
Terminated Class I, Class II Drugs
- Recall started
- 20 April 2020
- Terminated
- 16 October 2023
- Reason
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Distribution
- USA Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1296-2020, D-1297-2020
- 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 per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich,
- 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 Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx on
Terminated Class I Drugs
- Recall started
- 28 June 2019
- Terminated
- 20 September 2022
- Reason
- Presence of Particulate Matter; glass particulates
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1489-2019
- Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Terminated Class III Drugs
- Recall started
- 22 May 2019
- Terminated
- 28 January 2021
- Reason
- Failed Impurities/Degradation Specifications.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1386-2019
- Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Terminated Class I Drugs
- Recall started
- 15 November 2018
- Terminated
- 1 May 2023
- Reason
- Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
- Distribution
- Distributed Nationwide in the USA and Puerto RIco
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0299-2019, D-0298-2019
- SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620
- SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610
Terminated Class III Drugs
- Recall started
- 16 January 2018
- Terminated
- 17 September 2019
- Reason
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0426-2018
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Terminated Class I Drugs
- Recall started
- 27 October 2017
- Terminated
- 5 October 2020
- Reason
- Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0152-2018
- Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.