Fresenius Kabi DOXOrubicin Injection Recall: Cross Contamination Risk
Fresenius Kabi recalls DOXOrubicin Hydrochloride Injection due to trace octreotide contamination. This may cause cross-contamination with other products. Affected units have NDC 63323-883-05, batch 6120525.
Lower-risk recall
Cross Contamination with Other Products: trace amounts of octreotide found during testing
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What happened, in plain English
Fresenius Kabi is recalling a specific dose of DOXOrubicin injection because testing found trace amounts of octreotide. This cross-contamination risk could affect other medications if the product is used improperly. Read more at govinfonow.com/recall/36672-fresenius-kabi-doxorubicin-injection-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36672-fresenius-kabi-doxorubicin-injection-recall-cross-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0105-2021
Cite this page
“Fresenius Kabi DOXOrubicin Injection Recall: Cross Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36672-fresenius-kabi-doxorubicin-injection-recall-cross-contamination-risk. Based on FDA recall #D-0105-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0105-2021%22&limit=1).
Why it’s dangerous
Trace amounts of octreotide were detected during testing. This could lead to cross-contamination with other products, potentially causing unintended medication interactions or adverse effects.
Who’s affected
Healthcare professionals using this chemotherapy drug for cancer treatment. Patients receiving this injection are most at risk if cross-contamination occurs.
How to tell if you have this one
Check for the NDC code 63323-883-05 and batch number 6120525 on the vial label. The product is a single-dose vial of 10 mg/5 mL DOXOrubicin injection.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 63323-883-05 and batch 6120525 on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 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
Is this product safe to use?
The recall states trace octreotide was found, but the product is still considered safe for use if handled properly. However, the manufacturer recommends checking for contamination.
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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-0105-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0105-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.