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Fresenius Kabi USA, LLC recall records

44 reported ongoing

52 records in this archive. Latest source date Aug 10, 2026. 1 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Aug 10, 2026FDA drug enforcement

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.

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Class IReported ongoing

Distribution: Nationwide in the USA

Official source

Aug 4, 2026FDA drug enforcement

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 ...

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Class IReported ongoing

Distribution: Nationwide within the USA.

Official source

Jul 16, 2026FDA drug enforcement

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: 6332...

Presence of Particulate Matter: Hair was found in product

Class IIReported ongoing

Distribution: Nationwide within in the USA

Official source

Jul 16, 2026FDA drug enforcement

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-20...

Presence of Particulate Matter: Hair was found in products

Class IIReported ongoing

Distribution: Nationwide within in the USA

Official source

Jul 16, 2026FDA drug enforcement

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 ND...

Presence of Particulate Matter: Hair was found in products

Class IIReported ongoing

Distribution: Nationwide within in the USA

Official source

Jul 16, 2026FDA drug enforcement

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 6...

Presence of Particulate Matter: Hair was found in products

Class IIReported ongoing

Distribution: Nationwide within in the USA

Official source

Jul 16, 2026FDA drug enforcement

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 6...

Presence of Particulate Matter: Hair was found in products

Class IIReported ongoing

Distribution: Nationwide within in the USA

Official source

May 14, 2026FDA drug enforcement

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)

Failed Impurities/Degradations Specifications

Class IIIReported ongoing

Distribution: US Nationwide.

Official source

May 6, 2026FDA device enforcement

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

Class IReported ongoing

Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Official source

May 6, 2026FDA device enforcement

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically...

Class IReported ongoing

Distribution: Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;

Official source

Mar 11, 2026FDA drug enforcement

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, ...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 652...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

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 ("Fresenius Kabi"), Lake Zurich, IL 60...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin La...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lak...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Mar 11, 2026FDA drug enforcement

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed ...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide , Alaska, and Puerto Rico.

Official source

Reasons in these listed records

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Presence of Particulate Matter: Hair was found in product
Presence of Particulate Matter: Hair was found in products

These examples come from this result page and are not a ranking of every recall reason.

Checking Fresenius Kabi USA, LLC

Is there a recall on fresenius kabi usa, llc right now?

This archive contains 52 records, including 44 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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