Medications & Supplements/Prescription Drugs

0.9% Sodium Chloride Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: June 23, 2025

Summary

Fresenius Medical Care Holdings, Inc. has recalled 3,651,468 containers of 0.9% Sodium Chloride Injection, USP, in flexible plastic containers. This prescription medication, which is used for intravenous infusion or wound cleansing, is being recalled because the sterility of the product cannot be guaranteed. The recall affects over 150 different lot numbers with expiration dates ranging from November 2025 to March 2026.

Risk

A lack of sterility assurance in an injectable drug poses a significant risk of infection if the product is contaminated with bacteria or other microorganisms. This is particularly dangerous for vulnerable patients or those receiving the medication directly into their bloodstream.

What You Should Do

This recall affects 0.9% Sodium Chloride Injection, USP (NDC 49230-300-10) sold in flexible plastic containers under the Fresenius Medical Care North America brand.
Check the lot number and expiration date printed on the plastic container or its outer packaging. The recall involves over 150 specific lot numbers starting with codes 24PU, 24SU, 25AU, 25BU, and 25CU. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer, Fresenius Medical Care North America, at 1-800-323-5188 or your medical distributor to arrange for the return of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

Other Action

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, Flexible Plastic Container (Rx Only)

Lot Numbers (177):

24PU06037 (Exp 11/30/2025)

24PU06038 (Exp 11/30/2025)

24PU06040 (Exp 11/30/2025)

24PU06041 (Exp 11/30/2025)

24PU06042 (Exp 11/30/2025)

24PU06043 (Exp 11/30/2025)

24PU06044 (Exp 11/30/2025)

24PU06045 (Exp 11/30/2025)

24PU0646 (Exp 11/30/2025)

24PU06047 (Exp 11/30/2025)

24PU06048 (Exp 11/30/2025)

24PU06049 (Exp 11/30/2025)

24PU06050 (Exp 11/30/2025)

24PU06052 (Exp 11/30/2025)

24PU06053 (Exp 11/30/2025)

24PU06054 (Exp 11/30/2025)

24PU06055 (Exp 11/30/2025)

24SU06001 (Exp 12/31/25)

24SU06002 (Exp 12/31/25)

24SU06003 (Exp 12/31/25)

24SU06004 (Exp 12/31/25)

24SU06005 (Exp 12/31/25)

24SU06006 (Exp 12/31/25)

24SU06007 (Exp 12/31/25)

24SU06009 (Exp 12/31/25)

24SU06010 (Exp 12/31/25)

24SU06011 (Exp 12/31/25)

24SU06012 (Exp 12/31/25)

24SU06013 (Exp 12/31/25)

24SU06014 (Exp 12/31/25)

24SU06015 (Exp 12/31/25)

24SU06016 (Exp 12/31/25)

24SU06017 (Exp 12/31/25)

24SU06018 (Exp 12/31/25)

24SU06019 (Exp 12/31/25)

24SU06020 (Exp 12/31/25)

24SU06021 (Exp 12/31/25)

24SU06022 (Exp 12/31/25)

24SU06023 (Exp 12/31/25)

24SU06024 (Exp 12/31/25)

24SU06025 (Exp 12/31/25)

24SU06026 (Exp 12/31/25)

24SU06028 (Exp 12/31/25)

24SU06029 (Exp 12/31/25)

24SU06030 (Exp 12/31/25)

24SU06031 (Exp 12/31/25)

24SU06032 (Exp 12/31/25)

24SU06033 (Exp 12/31/25)

24SU06034 (Exp 12/31/25)

24SU06035 (Exp 12/31/25)

NDC:

49230-300-10

Recall #: D-0490-2025; Quantity: 3,651,468 containers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96877

Status: Active

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: Medical supply distributors; Hospitals; Dialysis centers; Infusion centers

Manufactured In: United States

Units Affected: 3,651,468 containers

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

This recall affects 0.9% Sodium Chloride Injection, USP (NDC 49230-300-10) sold in flexible plastic containers under the Fresenius Medical Care North America brand.

Check the lot number and expiration date printed on the plastic container or its outer packaging. The recall involves over 150 specific lot numbers starting with codes 24PU, 24SU, 25AU, 25BU, and 25CU. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact the manufacturer, Fresenius Medical Care North America, at 1-800-323-5188 or your medical distributor to arrange for the return of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container (Rx Only)

Lot Numbers (177):

24PU06037 (Exp 11/30/2025)

24PU06038 (Exp 11/30/2025)

24PU06040 (Exp 11/30/2025)

24PU06041 (Exp 11/30/2025)

24PU06042 (Exp 11/30/2025)

24PU06043 (Exp 11/30/2025)

24PU06044 (Exp 11/30/2025)

24PU06045 (Exp 11/30/2025)

24PU0646 (Exp 11/30/2025)

24PU06047 (Exp 11/30/2025)

24PU06048 (Exp 11/30/2025)

24PU06049 (Exp 11/30/2025)

24PU06050 (Exp 11/30/2025)

24PU06052 (Exp 11/30/2025)

24PU06053 (Exp 11/30/2025)

24PU06054 (Exp 11/30/2025)

24PU06055 (Exp 11/30/2025)

24SU06001 (Exp 12/31/25)

24SU06002 (Exp 12/31/25)

24SU06003 (Exp 12/31/25)

24SU06004 (Exp 12/31/25)

24SU06005 (Exp 12/31/25)

24SU06006 (Exp 12/31/25)

24SU06007 (Exp 12/31/25)

24SU06009 (Exp 12/31/25)

24SU06010 (Exp 12/31/25)

24SU06011 (Exp 12/31/25)

24SU06012 (Exp 12/31/25)

24SU06013 (Exp 12/31/25)

24SU06014 (Exp 12/31/25)

24SU06015 (Exp 12/31/25)

24SU06016 (Exp 12/31/25)

24SU06017 (Exp 12/31/25)

24SU06018 (Exp 12/31/25)

24SU06019 (Exp 12/31/25)

24SU06020 (Exp 12/31/25)

24SU06021 (Exp 12/31/25)

24SU06022 (Exp 12/31/25)

24SU06023 (Exp 12/31/25)

24SU06024 (Exp 12/31/25)

24SU06025 (Exp 12/31/25)

24SU06026 (Exp 12/31/25)

24SU06028 (Exp 12/31/25)

24SU06029 (Exp 12/31/25)

24SU06030 (Exp 12/31/25)

24SU06031 (Exp 12/31/25)

24SU06032 (Exp 12/31/25)

24SU06033 (Exp 12/31/25)

24SU06034 (Exp 12/31/25)

24SU06035 (Exp 12/31/25)

NDC:

49230-300-10

Recall #: D-0490-2025; Quantity: 3,651,468 containers