Fresenius Kabi Usa, Llc
Lake Zurich, IL, United States
This page shows every FDA and USDA recall linked to Fresenius Kabi Usa, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
30
Total Recalls
2012
First Recall
2025
Most Recent
7
Class I (Most Serious)
Drug: 29
Device: 1
Class II: 13
Class III: 9
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63...
Dec 3, 2025
· Drug
Class I
Ongoing
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%...
Jan 25, 2023
· Drug
Class II
Terminated
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC...
Mar 30, 2022
· Drug
Class I
Terminated
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25...
Feb 3, 2021
· Drug
Class I
Terminated
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx on...
Jan 6, 2021
· Drug
Class II
Terminated
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL...
Dec 30, 2020
· Drug
Class II
Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle,...
Dec 16, 2020
· Drug
Class I
Terminated
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial...
Dec 2, 2020
· Drug
Class III
Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infus...
Sep 2, 2020
· Drug
Class I
Terminated
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich,...
Jul 22, 2020
· Drug
Class III
Terminated
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25...
Jun 17, 2020
· Drug
Class I
Terminated
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made...
Feb 7, 2018
· Drug
Class III
Terminated
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 6...
Apr 12, 2017
· Drug
Class III
Terminated
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceutica...
Feb 8, 2017
· Drug
Class II
Terminated
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi...
Jun 22, 2016
· Drug
Class II
Terminated
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by F...
Jun 1, 2016
· Drug
Class II
Terminated
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dos...
Apr 20, 2016
· Drug
Class II
Terminated
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047,...
Apr 20, 2016
· Drug
Class III
Terminated
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fr...
Aug 19, 2015
· Drug
Class III
Terminated
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporat...
Jul 22, 2015
· Drug
Class II
Terminated
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfit...
Jun 10, 2015
· Drug
Class II
Terminated
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial...
Jan 29, 2015
· Device
Terminated
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceutical...
Dec 17, 2014
· Drug
Class II
Terminated
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged un...
Jan 29, 2014
· Drug
Class II
Terminated
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuti...
Dec 25, 2013
· Drug
Class III
Terminated
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx...
Dec 4, 2013
· Drug
Class III
Terminated
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Pr...
Sep 4, 2013
· Drug
Class I
Terminated
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10...
Jul 24, 2013
· Drug
Class II
Terminated
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manu...
Jul 17, 2013
· Drug
Class II
Terminated
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceutic...
Jul 17, 2013
· Drug
Class III
Terminated