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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

Hospira Epinephrine and Sodium Bicarbonate Injections Recalled for Sterility

Agency Publication Date: August 18, 2025
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Summary

Pfizer is voluntarily recalling approximately 65,370 units of Hospira brand injectable medications, including Epinephrine Injection and 8.4% Sodium Bicarbonate Injection. The recall includes 49,620 vials of Epinephrine (1mg/10mL) and 15,750 vials of 8.4% Sodium Bicarbonate (50mEq/50 mL) distributed to clinical settings. These products are being recalled due to a lack of assurance of sterility, which means the medications might not be completely free of germs or bacteria. To date, no injuries or adverse health events have been reported related to this recall.

Risk

Using an injectable medication that is not sterile can lead to serious, life-threatening infections, including sepsis or localized abscesses at the injection site. This is particularly dangerous for patients already in critical care or with weakened immune systems.

What You Should Do

  1. This recall affects Hospira brand Epinephrine Injection, USP (1mg/10mL) and 8.4% Sodium Bicarbonate Injection, USP (50mEq/50 mL).
  2. Check your supply for Epinephrine lots LY3681, LY4360, and LY4416 (all with expiration date 02/28/2026) and Sodium Bicarbonate lot LH2671 (expiration date 11/30/2026).
  3. Stop using the recalled products immediately to prevent patient harm.
  4. Contact Pfizer or your medical supply distributor to arrange for the return and replacement of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL)by Hospira
Variants: 1mg/10mL (0.1 mg/mL), Vial, Case
Lot Numbers:
LY3681 (Exp. 02/28/2026)
LY4360 (Exp. 02/28/2026)
LY4416 (Exp. 02/28/2026)
NDC:
0409-4933-05
0409-4933-10

Distributed by Hospira, Inc.

Product: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL)by Hospira
Variants: 8.4%, 50mEq/50 mL (1 mEq/mL), Vial, Case
Lot Numbers:
LH2671 (Exp. 11/30/2026)
NDC:
0409-6637-24
00409-6637-14

Distributed by Hospira, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97364
Status: Active
Manufacturer: PFIZER INC
Sold By: Wholesalers; Hospitals; Infusion Centers; Healthcare Facilities
Manufactured In: United States
Units Affected: 2 products (49,620 vials; 15,750 vials)
Distributed To: Nationwide
Agency Last Updated: August 20, 2025

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.