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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

Heparin Sodium Injection Recalled for Low Potency

Agency Publication Date: March 6, 2023
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Summary

B. Braun Medical Inc. is recalling 30,672 units of Heparin Sodium Injection (25,000 USP units per 250 mL) in 5% Dextrose. This medication, which is used to prevent and treat blood clots, is being recalled because it was found to be subpotent, meaning it does not contain the required amount of the active ingredient to be fully effective. No incidents or injuries have been reported to date regarding this issue.

Risk

If the medication is subpotent, it may not provide enough anticoagulation to effectively prevent or treat blood clots. This failure could lead to serious medical conditions, including deep vein thrombosis, pulmonary embolism, or stroke.

What You Should Do

  1. This recall affects Heparin Sodium Injection (25,000 USP units per 250 mL) in 5% Dextrose, sold in 250 mL Excel containers with NDC 0264-9587-20.
  2. Check your stock for lot number J2C017 with an expiration date of 9/30/2023.
  3. Stop using the recalled product immediately. Contact B. Braun Medical Inc. or your distributor to arrange for the return of any remaining units from this lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Heparin Sodium Injection (25,000 USP units per 250 mL) in 5% Dextrose Injection
Variants: 250 mL Excel Container
Lot Numbers:
J2C017 (Exp 9/30/2023)
NDC:
0264-9587-20

Recall #: D-0434-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91769
Status: Resolved
Manufacturer: B. Braun Medical Inc
Sold By: Hospitals; Clinics; Pharmacies
Manufactured In: United States
Units Affected: 30672
Distributed To: Nationwide
Agency Last Updated: May 10, 2023

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.