Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: DOXOrubicin Hydrochloride Injection Recalled for Octreotide Contamination

Agency Publication Date: November 24, 2020
Share:
Sign in to monitor this recall

Summary

Fresenius Kabi USA, LLC has recalled 16,986 vials of DOXOrubicin Hydrochloride Injection, USP (10 mg / 5 mL). This recall was initiated after testing discovered trace amounts of another drug, octreotide, within the product. This cross-contamination can lead to patients receiving unintended medication during their treatment. Consumers should contact their healthcare provider or pharmacist regarding any use of the affected medication.

Risk

The presence of trace amounts of octreotide in a doxorubicin injection means patients are being exposed to an unintended pharmacological agent. This cross-contamination can cause unexpected side effects or interfere with the primary cancer treatment being administered.

What You Should Do

  1. Check your medication vials for DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL) in a 5 mL fill, 6 mL single-dose vial.
  2. Verify if your product belongs to Batch 6120525 with an expiration date of 11/2020 and NDC number 63323-883-05.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or are currently using the affected batch.
  4. Return any unused product from this batch to the pharmacy or place of purchase for a refund.
  5. Contact Fresenius Kabi USA, LLC for further instructions regarding the return process or if you have specific product questions.
  6. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: DOXOrubicin Hydrochloride Injection, USP (10 mg / 5 mL)
Model:
NDC: 63323-883-05
Recall #: D-0105-2021
Lot Numbers:
6120525 (Exp 11/2020)
Date Ranges: 11/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86765
Status: Resolved
Manufacturer: Fresenius Kabi USA, LLC
Manufactured In: United States
Units Affected: 16,986 vials
Distributed To: Nationwide

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.