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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 Inc.: 5% Dextrose Injection Recalled for Potential Bag Leaks and Sterility Concerns

Agency Publication Date: December 2, 2021
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Summary

Approximately 765 bags of 5% Dextrose Injection (generic name: dextrose 5% in water), an intravenous (IV) solution, have been recalled because the bags may leak. These 50 mL ADD-Vantage Units, distributed by Hospira, INC., were found to have a lack of sterility assurance which can lead to the solution becoming contaminated. Consumers and healthcare providers should check for lot number 4923608 with an expiration date of May 1, 2022.

Risk

A leaking IV bag can compromise the sterility of the solution, allowing bacteria or other pathogens to enter the fluid. If contaminated fluid is administered to a patient, it could lead to serious, life-threatening infections.

What You Should Do

  1. Immediately check your supply for 50 mL bags of 5% Dextrose Injection (NDC 0409-7100-68 or 0409-7100-66) distributed by Hospira.
  2. Identify if your product is affected by looking for Lot number 4923608 with an expiration date of 1MAY2022 printed on the packaging.
  3. If you have an affected bag, do not use it; contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused, affected product to the place of purchase for a refund and contact Pfizer at 1-800-438-1985 for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

💰Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit
Model:
NDC 0409-7100-68
0409-7100-66
Lot Numbers:
4923608 (Exp. 1MAY2022)
Date Ranges: Expiration Date: 1MAY2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89100
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospira, INC.
Manufactured In: United States
Units Affected: 765 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 · 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.