Fresenius Kabi USA, LLC

FDA recalling firm · 67 enforcement events · 95 product records · 2012–2026 · IL, MA

Fresenius Kabi USA, LLC has 67 FDA enforcement events on this register (95 product records) between 2012 and 2026: 45 drug and 22 device; the busiest year was 2025 with 9.

37% of its events are Class I; the most common class is Class II (30). 24 events are listed as ongoing; the recalling firm's address is in IL and MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
10 Aug 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.	Drug	Class I	1	Ongoing
4 Aug 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 NDC Number 76045-004-11	Drug	Class I	1	Ongoing
16 Jul 2026	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	Drug	Class II	5	Ongoing
14 May 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)	Drug	Class III	1	Ongoing
6 May 2026	Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004	Device	Class I	1	Ongoing
6 May 2026	LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.	Device	Class I	1	Ongoing
11 Mar 2026	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, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).	Drug	Class II	14	Ongoing
4 Feb 2026	The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.	Device	Class II	1	Ongoing
21 Nov 2025	Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.	Device	Class II	1	Ongoing
14 Nov 2025	Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.	Device	Class I	1	Ongoing
6 Nov 2025	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).	Drug	Class I	1	Ongoing
3 Nov 2025	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.	Device	Class I	1	Ongoing
3 Nov 2025	Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.	Device	Class II	1	Ongoing
3 Sep 2025	Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.	Device	Class II	1	Ongoing
24 Jun 2025	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.	Device	Class II	4	Ongoing
12 May 2025	IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.	Device	Class I	1	Ongoing
10 Jan 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 administration.	Device	Class I	1	Ongoing
6 Dec 2024	Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004	Device	Class I	1	Ongoing
30 Aug 2024	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.	Device	Class I	1	Ongoing
1 Aug 2024	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.	Device	Class I	1	Ongoing
7 Mar 2024	LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.	Device	Class I	1	Ongoing
29 Nov 2023	Ivenix Infusion System (IIS), Large Volume Pump LVP-0004	Device	Class I	1	Ongoing
10 May 2023	LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004	Device	Class II	1	Completed
10 Mar 2023	Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004	Device	Class I	1	Ongoing
22 Nov 2022	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 Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.	Drug	Class II	3	Terminated
16 Sep 2022	LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004	Device	Class II	1	Completed
8 Sep 2022	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0	Device	Class I	1	Terminated
22 Apr 2022	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 fluids through clinically accepted routes of administration.	Device	Class II	1	Ongoing
4 Mar 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 Zurich, IL 60047	Drug	Class I	1	Terminated
17 Sep 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	Drug	Class II	1	Terminated
25 Jun 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. Vial NDC 63323-487-07, Tray NDC 63323-487-37	Drug	Class II	1	Terminated
23 Dec 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, IL 60047.	Drug	Class I	1	Terminated
17 Dec 2020	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	Drug	Class II	1	Terminated
10 Dec 2020	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, Fresenius Kabi, Lake Zurich, IL 60047.	Drug	Class II	1	Terminated
17 Nov 2020	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	Drug	Class I	1	Terminated
17 Nov 2020	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	Drug	Class III	1	Terminated
22 Jul 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 63323-671-05	Drug	Class I	1	Terminated
13 Jul 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	Drug	Class III	1	Terminated
20 Apr 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, IL 60047.	Drug	Class I	2	Terminated
28 Jun 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]	Drug	Class I	1	Terminated
22 May 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	Drug	Class III	1	Terminated
15 Nov 2018	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	Drug	Class I	2	Terminated
16 Jan 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	Drug	Class III	1	Terminated
27 Oct 2017	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	Drug	Class I	1	Terminated
16 Mar 2017	Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05	Drug	Class III	1	Terminated
16 Dec 2016	MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05	Drug	Class II	1	Terminated
4 May 2016	OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.	Drug	Class II	2	Terminated
25 Apr 2016	Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37	Drug	Class II	1	Terminated
7 Apr 2016	Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.	Drug	Class III	1	Terminated
5 Apr 2016	Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10	Drug	Class II	1	Terminated
28 Jul 2015	Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01	Drug	Class III	1	Terminated
4 Jun 2015	Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20	Drug	Class II	1	Terminated
28 Apr 2015	KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.	Drug	Class II	1	Terminated
19 Dec 2014	HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710	Device	Class II	1	Terminated
12 Nov 2014	GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20	Drug	Class II	1	Terminated
13 Aug 2014	PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01	Drug	Class II	1	Terminated
2 May 2014	Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02	Drug	Class II	2	Terminated
14 Apr 2014	HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01	Drug	Class III	1	Terminated
22 Jan 2014	Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose…	Drug	Class II	1	Terminated
6 Dec 2013	FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11	Drug	Class III	1	Terminated
8 Nov 2013	PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India	Drug	Class III	1	Terminated
31 Oct 2013	Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.	Drug	Class II	1	Terminated
1 Jul 2013	Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02	Drug	Class II	1	Terminated
24 Jun 2013	Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.	Drug	Class II	1	Terminated
25 May 2013	Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50	Drug	Class I	1	Terminated
21 May 2013	Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11	Drug	Class III	1	Terminated
27 Sep 2012	MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.	Drug	Class II	3	Terminated

By type and class

Drug45

Device22

Class II30

Class I25

Class III12

Class I: 37% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Fresenius Kabi USA, LLC by year initiated.

Questions and answers

How many FDA recalls has Fresenius Kabi USA, LLC had?

67 enforcement events (95 product records) on this register, 2012–2026: 45 drug, 22 device.

Are any Fresenius Kabi USA, LLC recalls ongoing?

24 events are listed as ongoing in the current openFDA export.

What class are Fresenius Kabi USA, LLC recalls?

30 Class II, 25 Class I, 12 Class III. 37% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.