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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

Pfizer Heparin Sodium Injection Recalled for Potential Leaks and Sterility Risk

Agency Publication Date: January 5, 2023
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Summary

Pfizer Inc. has recalled 62,088 bags of Heparin Sodium (heparin sodium) injection because the bags have the potential to leak. This defect causes a lack of assurance of sterility for the medication, which is intended for intravenous administration. The recall includes 1,000 mL bags distributed nationwide by Hospira, Inc. with lot number 5935283.

Risk

Leaking bags can compromise the sterility of the injectable medication, allowing microorganisms to enter the solution. Using a contaminated product poses a serious risk of infection or systemic illness to patients.

What You Should Do

  1. This recall affects Heparin Sodium 2,000 USP Units in 0.9% Sodium Chloride Injection (1,000 mL bags) with NDC numbers 0409-7620-59 (Case) and 0409-7620-49 (Single).
  2. Identify affected bags by checking for lot number 5935283 with an expiration date of 12/01/2023.
  3. Stop using the recalled product immediately.
  4. Contact Pfizer Inc. or your distributor to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection (1,000 mL bags)
Variants: 1,000 mL bags, 2,000 USP Units, 2 USP Units/mL
Lot Numbers:
5935283 (Exp. 12/01/2023)
NDC:
0409-7620-59
0409-7620-49

Distributed by Hospira, Inc. Case and Single Unit NDC codes both affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91379
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospira, Inc.
Manufactured In: United States
Units Affected: 62,088 bags
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.