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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 Heparin Sodium Injection Recalled for Low Potency

Agency Publication Date: May 16, 2023
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Summary

B. Braun Medical Inc. is recalling 1,380 units of Heparin Sodium (25,000 USP units per 250mL) in 5% Dextrose injection. The recall was issued because the medication was found to be subpotent, which means it has lower levels of anti-factor IIa potency than required. No incidents or injuries have been reported to date regarding this issue.

Risk

If a patient receives a low-potency dose of Heparin, which is a blood thinner, it may not effectively prevent or treat blood clots. This could lead to serious medical complications from untreated clotting conditions.

What You Should Do

  1. This recall affects Heparin Sodium (25,000 USP units per 250mL) in 5% Dextrose injection, sold in 250 ml Excel Containers under NDC 0264-9587-20. Only lot number J1P154N with an expiration date of May 31, 2023, is included.
  2. Stop using the recalled product immediately. Contact B. Braun Medical Inc. or your distributor to arrange for the return of any remaining stock.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more 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: Heparin Sodium in 5% Dextrose injection (25,000 USP units per 250mL)
Variants: 250 ml Excel Container, 100 USP units per mL
Lot Numbers:
J1P154N (Exp 31 May, 2023)
NDC:
0264-9587-20

API from Spain

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92292
Status: Resolved
Manufacturer: B. Braun Medical Inc
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States, Spain
Units Affected: 1,380
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.