Fresenius Kabi USA, LLC: 73 recalls on record

Recalls filed with 1 agency: FDA (73).

First recall on record: July 17, 2013. Most recent: September 2, 2026.

Risk classification: Class I: 16 · Class II: 47 · Class III: 10

Most recent recalls

DateAgencyProduct
December 3, 2025FDAFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius …D-0182-2026
August 6, 2025FDALVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Q…Z-2235-2025
October 2, 2024FDAIvenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior…Z-3153-2024
September 11, 2024FDALVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25…Z-2721-2024
April 17, 2024FDALVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.Z-1484-2024
March 20, 2024FDALVP software of the Ivenix Infusion System (IIS); LVP-SW-0004Z-1283-2024
March 20, 2024FDALVP software of the Ivenix Infusion System (IIS), LVP-SW-0004Z-1282-2024
January 25, 2023FDASensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (…D-0127-2023
January 25, 2023FDASensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (…D-0128-2023
January 25, 2023FDASensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,0…D-0129-2023
October 12, 2022FDAIvenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0Z-0002-2023
March 30, 2022FDASodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 v…D-0750-2022
October 6, 2021FDAMorphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius K…D-0856-2021
July 14, 2021FDAXylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP),…D-0651-2021
January 6, 2021FDAKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Si…D-0184-2021
December 30, 2020FDASensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL …D-0172-2021
December 16, 2020FDADexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 m…D-0120-2021
December 2, 2020FDADOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL v…D-0105-2021
September 2, 2020FDADexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), …D-1537-2020
July 22, 2020FDAFosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Freseniu…D-1391-2020
June 17, 2020FDAKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Si…D-1297-2020
June 17, 2020FDAKetorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (…D-1296-2020
December 12, 2018FDASODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray,…D-0298-2019
December 12, 2018FDASODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray,…D-0299-2019
February 7, 2018FDAVecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zu…D-0426-2018

Questions about this company

How many recalls does Fresenius Kabi USA, LLC have?
Recalert has 73 U.S. recalls on record for Fresenius Kabi USA, LLC, published between July 17, 2013 and September 2, 2026.
Which agencies have handled Fresenius Kabi USA, LLC recalls?
Fresenius Kabi USA, LLC appears as the recalling firm in recalls from: FDA (73).

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