Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
DOXOrubicin Hydrochloride Injection Recalled by Mylan Institutional LLC Due to Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Institutional LLC directly.
Affected Products
DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.
Quantity: 936 vials
Why Was This Recalled?
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Institutional LLC
Mylan Institutional LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report