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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

Doxil (doxorubicin hydrochloride) Recalled for Temperature Deviations

Agency Publication Date: October 17, 2023
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Summary

Baxter Healthcare Corporation is recalling 472 vials of Doxil (doxorubicin hydrochloride liposome injection) because the medication was exposed to temperatures higher than the labeled storage conditions during transportation. This lot was released for distribution by mistake after the storage deviation occurred. No injuries or adverse events have been reported to date regarding this recall.

Risk

Exposure to temperatures outside of the required storage range can compromise the stability and effectiveness of the medication. This may potentially reduce the therapeutic benefits of the drug for patients undergoing treatment.

What You Should Do

  1. This recall involves Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL single-dose vials, identified by NDC 0338-0067-01 and Lot MKZSU02 with an expiration date of June 30, 2024.
  2. Stop using the recalled product. Contact the manufacturer, Baxter Healthcare Corporation, or your distributor to arrange return.
  3. If you have health concerns or believe you may have received a dose from the affected lot, contact your healthcare provider or pharmacist immediately.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)
Variants: 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only
Lot Numbers:
MKZSU02 (Exp 6/30/2024)
NDC:
0338-0067-01

Quantity: 472 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93201
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: hospitals; clinics; specialty pharmacies
Manufactured In: United States
Units Affected: 472 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.