Teva Recalls mitoXANTRONE Injection Due to Impurity D Issues
Teva North America recalls specific lots of mitoXANTRONE Injection USP concentrate due to high levels of Impurity D. Check your vial details.
Recall notice
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Contact the company
What happened, in plain English
Teva North America is recalling a small quantity of mitoXANTRONE Injection USP (concentrate) because the product failed impurity specifications, specifically showing high results for Impurity D. The recall affects 2,506 vials distributed nationwide. No remedy or specific health risks are detailed in this record. Read more at govinfonow.com/recall/42597-teva-recalls-mitoxantrone-injection-due-to-impurity-d-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42597-teva-recalls-mitoxantrone-injection-due-to-impurity-d-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1451-2016
Cite this page
“Teva Recalls mitoXANTRONE Injection Due to Impurity D Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42597-teva-recalls-mitoxantrone-injection-due-to-impurity-d-issues. Based on FDA recall #D-1451-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1451-2016%22&limit=1).
Why it’s dangerous
The product failed to meet specifications for Impurity D, meaning the level of this impurity was higher than allowed. The record does not describe what Impurity D is or what health effects it might cause.
Who’s affected
This recall affects patients who have been prescribed or received the specific lot of mitoXANTRONE Injection USP concentrate from Teva Parenteral Medicines, Inc.
How to tell if you have this one
Look for a 10 mL Multiple Dose Vial of mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL). The specific recalled lot number is 31318659B with an expiration date of 02/17. The NDC is 0703-4685-01.
- Brand
Teva- Category
Drug
What to do — step by step
Check your medication details
Verify if you have the recalled lot number 31318659B of mitoXANTRONE Injection USP with expiration date 02/17.
Contact your healthcare provider
Speak with your doctor or pharmacist to determine the appropriate next steps for your treatment, as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled item?
The National Drug Code (NDC) is 0703-4685-01.
How many vials are affected by this recall?
A total of 2,506 vials are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1451-2016 (May 31, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1451-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.