Medications & Supplements/Prescription Drugs

Fresenius Kabi freeflex IV Injection Bags Recalled for Lack of Sterility

Agency Publication Date: April 3, 2026

Summary

Fresenius Kabi USA, LLC has recalled various freeflex IV injection bags, including Sodium Chloride and Dextrose solutions, because they may not be sterile. The recall affects a wide range of products used in clinical settings, such as 0.9% Sodium Chloride, 0.45% Sodium Chloride, and 5% Dextrose injections in various sizes from 50 mL to 1,000 mL. Using a non-sterile injectable medication can lead to serious, life-threatening infections, though no injuries have been reported to date. These products were distributed nationwide to hospitals and clinics across the U.S., Alaska, and Puerto Rico.

Risk

The products lack assurance of sterility, which means they could be contaminated with bacteria or other microorganisms. Injecting a non-sterile solution directly into a patient's bloodstream poses a high risk of causing severe systemic infections or sepsis.

What You Should Do

Identify if you have the recalled IV bags by checking the product name, NDC number, and lot numbers on the bag or case label.
Check for lot numbers such as 24EU10010, 6402296, 6402413, 23SU10008, 6402299, 6402428, and many others. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
Contact the manufacturer, Fresenius Kabi, or your distributor to arrange for the return of any affected inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

Other Action

Firm initiated recall via letter notification.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1,000 mL)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

24EU10010 (Exp 05/31/2027)

NDC:

17271-701-07

Distributed by BD; Manufactured by Fresenius Kabi

Product: 5% Dextrose Injection, USP (50 mL in 100 mL bag)

Variants: 2.5 g per 50 mL, freeflex bag

Lot Numbers:

6402296 (Exp 07/31/2026)

NDC:

65219-456-05

65219-456-60

Fresenius Kabi USA, LLC

Product: 0.45% Sodium Chloride Injection, USP (250 mL)

Variants: 1.125 grams per 250 mL, freeflex bag

Lot Numbers:

6402413 (Exp 02/29/2028)

NDC:

63323-626-03

63323-626-25

30 bags per case

Product: 0.9% Sodium Chloride Injection, USP (50 mL)

Variants: 450 mg per 50 mL, freeflex bag

Lot Numbers:

6402372 (Exp 08/31/2026)

6402374 (Exp 08/31/2026)

6402437 (Exp 10/31/2026)

NDC:

65219-466-05

65219-466-60

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (100 mL)

Variants: 900 mg per 100 mL, 100 mL in 100 mL freeflex bag

Lot Numbers:

6402299 (Exp 01/31/2027)

6402300 (Exp 01/31/2027)

6402301 (Exp 01/31/2027)

6402302 (Exp 01/31/2027)

6402303 (Exp 01/31/2027)

6402305 (Exp 02/28/2027)

6402398 (Exp 02/28/2027)

6402467 (Exp 04/30/2027)

6402577 (Exp 06/30/2027)

6402578 (Exp 06/30/2027)

NDC:

65219-468-05

65219-468-50

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (250 mL freeflex)

Variants: 2,250 mg per 250 mL, freeflex bag

Lot Numbers:

23SU10008 (Exp 12/31/2026)

24JU10003 (Exp 07/31/2027)

24LU10011 (Exp 09/30/2027)

24LU10012 (Exp 09/30/2027)

6402273 (Exp 01/31/2028)

6402275 (Exp 01/31/2028)

6402420 (Exp 03/31/2028)

6402421 (Exp 03/31/2028)

6402422 (Exp 03/31/2028)

6402423 (Exp 03/31/2028)

6402473 (Exp 04/30/2028)

6402474 (Exp 04/30/2028)

6402475 (Exp 04/30/2028)

6402476 (Exp 04/30/2028)

6402485 (Exp 04/30/2028)

6402516 (Exp 05/31/2028)

NDC:

65219-470-05

65219-470-30

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (500 mL freeflex)

Variants: 4,500 mg per 500 mL, freeflex bag

Lot Numbers:

24LU10013 (Exp 09/30/2027)

24LU10014 (Exp 09/30/2027)

24NU10001 (Exp 10/31/2027)

24NU10002 (Exp 10/31/2027)

NDC:

65219-472-05

65219-472-20

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (50 mL BD Packaging)

Variants: 50 mL x 60, distributed by BD

Lot Numbers:

6402428 (Exp 10/31/2026)

6402481 (Exp 11/30/2026)

6402482 (Exp 11/30/2026)

NDC:

17271-701-02

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (100 mL BD Packaging)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

6402153 (Exp 11/30/2026)

6402297 (Exp 01/31/2027)

6402298 (Exp 01/31/2027)

6402377 (Exp 02/28/2027)

6402378 (Exp 02/28/2027)

6402379 (Exp 02/28/2027)

6402429 (Exp 03/31/2027)

6402430 (Exp 03/31/2027)

6402431 (Exp 03/31/2027)

6402432 (Exp 03/31/2027)

6402433 (Exp 03/31/2027)

6402434 (Exp 04/30/2027)

6402512 (Exp 05/2027)

6402574 (Exp 06/30/2027)

6402576 (Exp 06/30/2027)

NDC:

17271-701-03

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (250 mL BD Packaging)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

6402290 (Exp 01/31/2028)

6402291 (Exp 01/31/2028)

6402411 (Exp 02/29/2028)

6402412 (Exp 03/31/2028)

6402419 (Exp 03/31/2028)

6402424 (Exp 03/31/2028)

6402425 (Exp 03/31/2028)

6402426 (Exp 03/31/2028)

6402427 (Exp 03/31/2028)

6402479 (Exp 05/31/2028)

6402480 (Exp 05/31/2028)

6402517 (Exp 05/31/2028)

6402571 (Exp 05/31/2028)

6402518 (Exp 06/30/2028)

NDC:

17271-701-05

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (500 mL Unit of Sale)

Variants: 900 mg per 100 mL, 500 mL x 20

Lot Numbers:

23DU10004 (Exp 04/30/2026)

23HU10006 (Exp 06/30/2026)

NDC:

65219-432-20

65219-432-85

Manufactured for Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (1,000 mL Fresenius Medical Care)

Variants: 900 mg per 100 mL, 1,000 mL x 10

Lot Numbers:

23SU10001 (Exp 12/31/2026)

24AU10003 (Exp 01/31/2027)

24AU10004 (Exp 01/31/2027)

24AU10005 (Exp 01/31/2027)

24AU10008 (Exp 01/31/2027)

24EU10001 (Exp 05/31/2027)

24EU10002 (Exp 05/31/2027)

24PU10002 (Exp 11/30/2027)

25BU10003 (Exp 02/29/2028)

25EU10005 (Exp 05/31/2028)

NDC:

65219-282-01

65219-282-10

Distributed by Fresenius Medical Care RTG, LLC

Product: 5% Dextrose Injection, USP (100 mL freeflex)

Variants: 5 g per 100 mL, 100 mL in 100 mL freeflex bag

Lot Numbers:

6402399 (Exp 02/28/2027)

6402400 (Exp 02/28/2027)

6402401 (Exp 02/28/2027)

NDC:

65219-464-05

65219-464-50

Fresenius Kabi USA, LLC

Product: 5% Dextrose Injection, USP (250 mL freeflex)

Variants: 12.5 g per 250 mL, 250 mL in 250 mL freeflex bag

Lot Numbers:

6402165 (Exp 05/30/2028)

NDC:

65219-458-05

65219-458-30

Fresenius Kabi USA, LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98581

Status: Active

Manufacturer: Fresenius Kabi USA, LLC

Sold By: BD Becton Dickson and Company; Fresenius Medical Care RTG, LLC

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the recalled IV bags by checking the product name, NDC number, and lot numbers on the bag or case label.

Check for lot numbers such as 24EU10010, 6402296, 6402413, 23SU10008, 6402299, 6402428, and many others. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

Contact the manufacturer, Fresenius Kabi, or your distributor to arrange for the return of any affected inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1,000 mL)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

24EU10010 (Exp 05/31/2027)

NDC:

17271-701-07

Distributed by BD; Manufactured by Fresenius Kabi

Product: 5% Dextrose Injection, USP (50 mL in 100 mL bag)

Variants: 2.5 g per 50 mL, freeflex bag

Lot Numbers:

6402296 (Exp 07/31/2026)

NDC:

65219-456-05

65219-456-60

Fresenius Kabi USA, LLC

Product: 0.45% Sodium Chloride Injection, USP (250 mL)

Variants: 1.125 grams per 250 mL, freeflex bag

Lot Numbers:

6402413 (Exp 02/29/2028)

NDC:

63323-626-03

63323-626-25

30 bags per case

Product: 0.9% Sodium Chloride Injection, USP (50 mL)

Variants: 450 mg per 50 mL, freeflex bag

Lot Numbers:

6402372 (Exp 08/31/2026)

6402374 (Exp 08/31/2026)

6402437 (Exp 10/31/2026)

NDC:

65219-466-05

65219-466-60

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (100 mL)

Variants: 900 mg per 100 mL, 100 mL in 100 mL freeflex bag

Lot Numbers:

6402299 (Exp 01/31/2027)

6402300 (Exp 01/31/2027)

6402301 (Exp 01/31/2027)

6402302 (Exp 01/31/2027)

6402303 (Exp 01/31/2027)

6402305 (Exp 02/28/2027)

6402398 (Exp 02/28/2027)

6402467 (Exp 04/30/2027)

6402577 (Exp 06/30/2027)

6402578 (Exp 06/30/2027)

NDC:

65219-468-05

65219-468-50

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (250 mL freeflex)

Variants: 2,250 mg per 250 mL, freeflex bag

Lot Numbers:

23SU10008 (Exp 12/31/2026)

24JU10003 (Exp 07/31/2027)

24LU10011 (Exp 09/30/2027)

24LU10012 (Exp 09/30/2027)

6402273 (Exp 01/31/2028)

6402275 (Exp 01/31/2028)

6402420 (Exp 03/31/2028)

6402421 (Exp 03/31/2028)

6402422 (Exp 03/31/2028)

6402423 (Exp 03/31/2028)

6402473 (Exp 04/30/2028)

6402474 (Exp 04/30/2028)

6402475 (Exp 04/30/2028)

6402476 (Exp 04/30/2028)

6402485 (Exp 04/30/2028)

6402516 (Exp 05/31/2028)

NDC:

65219-470-05

65219-470-30

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (500 mL freeflex)

Variants: 4,500 mg per 500 mL, freeflex bag

Lot Numbers:

24LU10013 (Exp 09/30/2027)

24LU10014 (Exp 09/30/2027)

24NU10001 (Exp 10/31/2027)

24NU10002 (Exp 10/31/2027)

NDC:

65219-472-05

65219-472-20

Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (50 mL BD Packaging)

Variants: 50 mL x 60, distributed by BD

Lot Numbers:

6402428 (Exp 10/31/2026)

6402481 (Exp 11/30/2026)

6402482 (Exp 11/30/2026)

NDC:

17271-701-02

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (100 mL BD Packaging)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

6402153 (Exp 11/30/2026)

6402297 (Exp 01/31/2027)

6402298 (Exp 01/31/2027)

6402377 (Exp 02/28/2027)

6402378 (Exp 02/28/2027)

6402379 (Exp 02/28/2027)

6402429 (Exp 03/31/2027)

6402430 (Exp 03/31/2027)

6402431 (Exp 03/31/2027)

6402432 (Exp 03/31/2027)

6402433 (Exp 03/31/2027)

6402434 (Exp 04/30/2027)

6402512 (Exp 05/2027)

6402574 (Exp 06/30/2027)

6402576 (Exp 06/30/2027)

NDC:

17271-701-03

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (250 mL BD Packaging)

Variants: 900 mg per 100 mL, Single Dose freeflex bag

Lot Numbers:

6402290 (Exp 01/31/2028)

6402291 (Exp 01/31/2028)

6402411 (Exp 02/29/2028)

6402412 (Exp 03/31/2028)

6402419 (Exp 03/31/2028)

6402424 (Exp 03/31/2028)

6402425 (Exp 03/31/2028)

6402426 (Exp 03/31/2028)

6402427 (Exp 03/31/2028)

6402479 (Exp 05/31/2028)

6402480 (Exp 05/31/2028)

6402517 (Exp 05/31/2028)

6402571 (Exp 05/31/2028)

6402518 (Exp 06/30/2028)

NDC:

17271-701-05

Manufactured by Fresenius Kabi for Becton, Dickinson and Company

Product: 0.9% Sodium Chloride Injection, USP (500 mL Unit of Sale)

Variants: 900 mg per 100 mL, 500 mL x 20

Lot Numbers:

23DU10004 (Exp 04/30/2026)

23HU10006 (Exp 06/30/2026)

NDC:

65219-432-20

65219-432-85

Manufactured for Fresenius Kabi USA, LLC

Product: 0.9% Sodium Chloride Injection, USP (1,000 mL Fresenius Medical Care)

Variants: 900 mg per 100 mL, 1,000 mL x 10

Lot Numbers:

23SU10001 (Exp 12/31/2026)

24AU10003 (Exp 01/31/2027)

24AU10004 (Exp 01/31/2027)

24AU10005 (Exp 01/31/2027)

24AU10008 (Exp 01/31/2027)

24EU10001 (Exp 05/31/2027)

24EU10002 (Exp 05/31/2027)

24PU10002 (Exp 11/30/2027)

25BU10003 (Exp 02/29/2028)

25EU10005 (Exp 05/31/2028)

NDC:

65219-282-01

65219-282-10

Distributed by Fresenius Medical Care RTG, LLC

Product: 5% Dextrose Injection, USP (100 mL freeflex)

Variants: 5 g per 100 mL, 100 mL in 100 mL freeflex bag

Lot Numbers:

6402399 (Exp 02/28/2027)

6402400 (Exp 02/28/2027)

6402401 (Exp 02/28/2027)

NDC:

65219-464-05

65219-464-50

Fresenius Kabi USA, LLC

Product: 5% Dextrose Injection, USP (250 mL freeflex)

Variants: 12.5 g per 250 mL, 250 mL in 250 mL freeflex bag

Lot Numbers:

6402165 (Exp 05/30/2028)

NDC:

65219-458-05

65219-458-30

Fresenius Kabi USA, LLC