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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

B Braun 0.9% Sodium Chloride Injection Recalled for Sterility Risk

Agency Publication Date: June 24, 2025
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Summary

B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP (500 mL). The recall was issued because pinholes were found in the packaging used during the manufacturing process, which can lead to leaks and a lack of sterility. This product is a sterile intravenous solution used to provide the body with water and salt.

Risk

The presence of pinholes compromises the sterile barrier of the container, which could allow bacteria or other contaminants to enter the solution. Using a non-sterile injectable drug can lead to serious, potentially life-threatening infections.

What You Should Do

  1. This recall affects 0.9% Sodium Chloride Injection USP (500 mL) packaged in Excel containers (NDC 0264-7800-10) with lot numbers J4L260, J4L261, J4L270, J4L271, and J4L280, all with an expiration date of February 28, 2027.
  2. Stop using the recalled product immediately.
  3. Contact B Braun Medical Inc. or your distributor to arrange for the return of any remaining inventory from the affected lots.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹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 (500 mL)
Variants: 500 mL excel containers, Packaged 24 per case, Rx only
Lot Numbers:
J4L260 (Exp 2/28/2027)
J4L261 (Exp 2/28/2027)
J4L270 (Exp 2/28/2027)
J4L271 (Exp 2/28/2027)
J4L280 (Exp 2/28/2027)
NDC:
0264-7800-10

Manufactured by B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA. Recall #: D-0491-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97059
Status: Active
Manufacturer: B BRAUN MEDICAL INC
Sold By: Hospitals; Clinics; Medical Wholesalers
Manufactured In: United States
Units Affected: 187,656 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 ยท 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.