Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Is Mitoxantrone recalled?
Not under an active recall.
Mitoxantrone was recalled 3 times in the past — all now closed. Most recent: Sep 13, 2016.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mitoxantrone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mitoxantrone recalls on record
none so far in 2026; 3 on record, newest first
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class I · High risk
MitoXANTRONE Injection
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
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