CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Velcade (bortezomib) for injection, 3.5 mg/vial recalled
Millennium Pharmaceuticals is recalling Velcade (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, Subcutaneous, distributed nationwide in the US. The recall was initiated on 30 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0425-2018
- FDA event ID
- 79083
- Recalling firm
- Millennium Pharmaceuticals, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2018
- FDA classified
- 14 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jan 2018 | Recall initiated by company | |
| 14 Feb 2018 | Classified by FDA | +15 days |
| 14 Feb 2018 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Confirmed reports of loose vial crimps.
Product as listed by the FDA
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01
Where it was distributed
Distributed nationwide. They estimate 4% of the product may be recovered.
Questions about this recall
Why was it recalled?
Defective Container: Confirmed reports of loose vial crimps.
Which lots are affected?
Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
Where was it sold?
Distributed nationwide. They estimate 4% of the product may be recovered.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.