Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
mitoXANTRONE Injection USP (concentrate) Recalled by Teva Pharmaceuticals USA Due to Failed Impurities/Degradation Specifications: potential failure to meet the...
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 Teva Pharmaceuticals USA directly.
Affected Products
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Quantity: 11,214 vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report