Amgen Kyprolis injection vials may have cracks causing contamination risk
Amgen recalls Kyprolis (carfilzom: 30mg vials) due to potential glass cracks that could allow contamination. Discard unused portions immediately. This is for intravenous use only.
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Lack of Assurance of Sterility: Potential cracks in glass vials
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What happened, in plain English
Amgen is recalling Kyprolis (carfilzomib) injection vials that may have cracks in the glass. These cracks could allow contamination, making the product unsafe for intravenous use. Affected vials must be discarded immediately. Read more at govinfonow.com/recall/42122-amgen-kyprolis-injection-vials-may-have-cracks-causing-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42122-amgen-kyprolis-injection-vials-may-have-cracks-causing-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0226-2017
Cite this page
“Amgen Kyprolis injection vials may have cracks causing contamination risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42122-amgen-kyprolis-injection-vials-may-have-cracks-causing-contamination-risk. Based on FDA recall #D-0226-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2017%22&limit=1).
Why it’s dangerous
The vials may have cracks that allow bacteria or other contaminants to enter the solution. This could cause serious infections or other health issues if the medication is injected.
Who’s affected
Patients prescribed Kyprolis injections by a doctor. Those with the specific vial lot numbers and expiration date are most at risk.
How to tell if you have this one
Check for vials labeled 'Kyprolis (carfilzomib) for injection, 30 mg per vial'. Look for lot numbers 1071559 or 1071629 with expiration date 05/18.
- Brand
Amgen- Category
Drug
What to do — step by step
Discard Unused Portion
Immediately discard any unused portion of the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “United States and Puerto Rico No foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0226-2017 (December 15, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0226-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.