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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 Lactated Ringer's and Sodium Chloride Injections Recalled for Sterility Risk

Agency Publication Date: August 14, 2025
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Summary

B. Braun Medical Inc. is recalling 97,188 containers of Lactated Ringer's Injection USP and 0.9% Sodium Chloride Injection USP in 1000mL Excel containers. The recall was issued because the sterile integrity of the bags cannot be guaranteed due to a potential fluid leak at one of the weld sites. These injectable medications are used to provide fluid and electrolyte replenishment and are typically administered in clinical or hospital settings.

Risk

The potential for fluid leakage at a weld site means the product may not be sterile. Administering a contaminated injection can lead to serious systemic infections or other life-threatening complications for patients.

What You Should Do

  1. This recall affects 1000mL Excel containers of Lactated Ringer's Injection USP (NDC 0264-7750-00) and 0.9% Sodium Chloride Injection USP (NDC 0264-7800-00) manufactured by B. Braun Medical Inc.
  2. Identify affected products by checking for the following lot numbers and expiration dates: Lactated Ringer's lots J5C802, J5C917, J5C918 and Sodium Chloride lot J5C919, all with an expiration date of August 31, 2027.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Lactated Ringer's Injection USP (1000mL)
Variants: Excel Container, L 7500, Rx Only, Sterile, Nonpyrogenic, Single dose container
Model:
L 7500
Lot Numbers:
J5C802 (Exp. 08/31/2027)
J5C917 (Exp. 08/31/2027)
J5C918 (Exp. 08/31/2027)
NDC:
0264-7750-00

Potential for fluid leakage at one of the weld sites.

Product: 0.9% Sodium Chloride Injection USP (1000mL)
Variants: Excel Container, L 8000, Rx Only, Sterile, Nonpyrogenic, Single dose container
Model:
L 8000
Lot Numbers:
J5C919 (Exp. 08/31/2027)
NDC:
0264-7800-00

Potential for fluid leakage at one of the weld sites.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97368
Status: Active
Manufacturer: B BRAUN MEDICAL INC
Sold By: Hospitals; Infusion Centers; Wholesalers; Authorized Distributors
Manufactured In: United States
Units Affected: 2 products (74,088 containers; 23,100 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.