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
September 2, 2026FDATyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufa…D-0827-2026
August 26, 2026FDAMorphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, …D-0788-2026
July 29, 2026FDALidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5…D-0726-2026
July 29, 2026FDANaropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),…D-0727-2026
July 29, 2026FDAXylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multipl…D-0729-2026
July 29, 2026FDAGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL…D-0725-2026
July 29, 2026FDAXylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multipl…D-0728-2026
June 17, 2026FDAEpinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake …D-0581-2026
June 10, 2026FDALVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Z-2223-2026
June 10, 2026FDAThe Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Z-2274-2026
June 10, 2026FDAIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Z-2224-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single…D-0433-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 …D-0427-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Do…D-0432-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single D…D-0430-2026
April 15, 2026FDA5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex b…D-0437-2026
April 15, 2026FDA0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a…D-0424-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single…D-0434-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 …D-0428-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only,…D-0425-2026
April 15, 2026FDA5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag,…D-0435-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single D…D-0431-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 1…D-0426-2026
April 15, 2026FDA0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Dr…D-0429-2026
April 15, 2026FDA5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag,…D-0436-2026

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.
What was the most recent Fresenius Kabi USA, LLC recall?
FDA recall D-0827-2026, published September 2, 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.
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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