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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

DOBUTamine Injection Recalled for Discolored Solution and Cracked Vials

Agency Publication Date: June 23, 2025
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Summary

Pfizer Inc. is recalling 98,410 vials of DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL) because of discolored solution caused by cracked vials. DOBUTamine (dobutamine) is a medication used in hospital settings for the short-term treatment of heart failure. The affected product was distributed by Hospira, Inc. and is intended for intravenous use only.

Risk

Cracked vials can allow contaminants to enter the solution, compromising its sterility and causing it to change color. Administering a non-sterile medication directly into a patient's bloodstream could result in serious infections or other life-threatening health complications.

What You Should Do

  1. This recall affects DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL) in 20 mL single-dose vials, lot number KA5023 with an expiration date of 02/28/2026. The product is found in cartons of 10 Fliptop Vials with NDC Carton code 0409-2344-02 and NDC Vial code 0409-2344-62.
  2. Stop using the recalled product immediately.
  3. Contact Pfizer Inc. or your distributor to arrange for the return of any unused vials from the affected lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls 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: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL)
Variants: 20 mL Single-dose Vial, Carton of 10 Fliptop Vials, Intravenous Use Only
Lot Numbers:
KA5023 (Exp 02/28/2026)
NDC:
0409-2344-02
0409-2344-62

Recall #: D-0489-2025; Distributed by Hospira, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96947
Status: Active
Manufacturer: Pfizer Inc.
Sold By: Hospira, Inc.; Pfizer Inc.
Manufactured In: Italy, United States
Units Affected: 98,410 vials
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.