Recalls · Brand

Fresenius Kabi USA, LLC recalls

Every recall we track for Fresenius Kabi USA, LLC — 94 in all, from 2012–2026 — plus the complaints and injury reports the public filed about them. 19 are rated “stop using now”.

94recalls

1,382complaints & reports

866injuries reported

122deaths reported

Recalls per year, by danger level

Recalls from Fresenius Kabi USA, LLC more than tripled in 2025 (12, up from 4 in 2024). 17% rated “stop using now”.

All FDA recall records for Fresenius Kabi USA, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Fresenius Kabi USA, LLC, by danger level
Year	Stop using now	Use caution	Lower risk	Not yet rated	Total
2017	0	1	1	0	2
2018	0	0	2	1	3
2019	0	1	0	1	2
2020	2	2	5	0	9
2021	1	0	1	0	2
2022	1	2	4	0	7
2023	0	3	0	0	3
2024	3	1	0	0	4
2025	2	3	6	1	12
2026 (to date)	3	5	7	10	25

Fresenius Kabi USA, LLC recalls before 2017

Recalls on record by year.

20166
20153
20146
20137
20123

Most common reasons for Fresenius Kabi USA, LLC recalls

Lack of Assurance of Sterility14
Potential for external cassette leaks4
Presence of Particulate Matter - found in reserve sample vials at the firm.4
Presence of Particulate Matter: Hair was found in products4
Cross Contamination with other products: trace amounts of lidocaine2

What to do if you have a recalled Fresenius Kabi USA, LLC product

Match the NDC and lot number on your bottle or box to the recall.
Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
Report side effects to FDA MedWatch.

See this week’s new recalls.

All Fresenius Kabi USA, LLC recalls

60 shown

Fresenius Kabi USA, LLC recall questions

How many recalls has Fresenius Kabi USA, LLC had?

94 recalls from Fresenius Kabi USA, LLC are on record with U.S. safety agencies, from 2012–2026 (70 drug, 24 medical device).

What is the most recent Fresenius Kabi USA, LLC recall?

Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,, dated Aug 10, 2026. Every Fresenius Kabi USA, LLC recall is listed on this page, newest first.

Why are Fresenius Kabi USA, LLC products recalled?

The most common reasons on record: Lack of Assurance of Sterility (14); Potential for external cassette leaks (4); Presence of Particulate Matter - found in reserve sample vials at the firm. (4); Presence of Particulate Matter: Hair was found in products (4).

What should I do if I have a recalled Fresenius Kabi USA, LLC product?

Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.

How do I get alerts for new Fresenius Kabi USA, LLC recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.

Fresenius Kabi USA, LLC recalls

Fresenius Kabi USA, LLC recalls before 2017

Most common reasons for Fresenius Kabi USA, LLC recalls

What to do if you have a recalled Fresenius Kabi USA, LLC product

All Fresenius Kabi USA, LLC recalls

Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,

Fresenius Kabi USA, LLC recalls Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or

Fresenius Kabi USA, LLC recalls 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

Fresenius Kabi USA, LLC recalls Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Fresenius Kabi USA, LLC recalls 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 recalls The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to

Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC

Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code:

Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.

Fresenius Kabi USA, LLC recalls LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg

Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for

Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC

Fresenius Kabi USA LLC recalls Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047,

Fresenius Kabi USA LLC recalls Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),

Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL

Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only,

Fresenius Kabi USA, LLC recalls Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single

Fresenius Kabi USA, LLC recalls Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only,

Fresenius Kabi USA, LLC recalls DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx

Fresenius Kabi USA, LLC recalls Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion,

Fresenius Kabi USA, LLC recalls Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;

Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL

Fresenius Kabi USA, LLC recalls Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,

Fresenius Kabi USA, LLC recalls Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC

Fresenius Kabi USA, LLC recalls SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,

Fresenius Kabi USA, LLC recalls Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,

Fresenius Kabi USA, LLC recalls Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per

Fresenius Kabi USA, LLC recalls Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC

Fresenius Kabi USA, LLC recalls MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC

Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius

Fresenius Kabi USA, LLC recalls Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC,

Fresenius Kabi USA, LLC recalls Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC

Fresenius Kabi USA, LLC recalls Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial,

Fresenius Kabi USA, LLC recalls Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius

Fresenius Kabi USA, LLC recalls Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive,

Fresenius Kabi USA, LLC recalls KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free],

Fresenius Kabi USA, LLC recalls GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP

Fresenius Kabi USA, LLC recalls PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg,

Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use

Fresenius Kabi USA LLC recalls HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC

Fresenius Kabi USA, LLC recalls 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

Fresenius Kabi USA, LLC recalls FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals,

Fresenius Kabi USA, LLC recalls PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only;

Fresenius Kabi USA, LLC recall questions