Millennium Pharmaceuticals VELCADE 3.5mg Vial Recall: Loose Vial Crimps Risk
Millennium Pharmaceuticals recalls VELCADE 3.5mg vials with loose vial crimps that could lead to injury during injection. Affected vials have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
Use caution until it’s fixed
Defective Container: Confirmed reports of loose vial crimps.
Contact the company
What happened, in plain English
Millennium Pharmaceuticals is recalling VELCADE 3.5mg vials due to loose vial crimps that may cause injury during injection. This recall affects patients using the medication as prescribed by their doctor. Read more at govinfonow.com/recall/40895-millennium-pharmaceuticals-velcade-3-5mg-vial-recall-loose-vial-crimps.
Source Summary by GovInfoNow · govinfonow.com/recall/40895-millennium-pharmaceuticals-velcade-3-5mg-vial-recall-loose-vial-crimps · Updated October 7, 2026 · FDA enforcement record: FDA #D-0425-2018
Cite this page
“Millennium Pharmaceuticals VELCADE 3.5mg Vial Recall: Loose Vial Crimps Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40895-millennium-pharmaceuticals-velcade-3-5mg-vial-recall-loose-vial-crimps. Based on FDA recall #D-0425-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0425-2018%22&limit=1).
Why it’s dangerous
Loose vial crimps can cause the vial to break or leak during injection, potentially leading to injury or incorrect dosing. This defect occurs in the container design and may not be visible to the user.
Who’s affected
Patients prescribed VELCADE 3.5mg vials by their doctor are most at risk. The recall applies to specific lot numbers and expiration dates of the medication.
How to tell if you have this one
Check the vial label for lot numbers #224161, #224546, or #224547 and expiration date 12/19. The product is only available by prescription and requires specific reconstitution instructions.
- Brand
Millennium Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Label
Look for lot numbers #224161, #224546, or #224547 and expiration date 12/19 on the vial label.
Contact Manufacturer
Reach out to Millennium Pharmaceuticals for further instructions on handling the recalled vials.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide. They estimate 4% of the product may be recovered.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 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-0425-2018 (January 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0425-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.