Millennium Pharmaceuticals Recalls VELCADE Injection Vials Due to Defective Crimps
Millennium Pharmaceuticals is recalling 154,372 vials of VELCADE (bortezomib) for injection due to confirmed reports of loose vial crimps.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a packaging issue (loose crimps) without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling or packaging errors.
Plain-English summary
Millennium Pharmaceuticals Inc. is recalling 154,372 vials of VELCADE (bortezomib) for injection, 3.5 mg/vial. The recall is due to confirmed reports of loose vial crimps, which are defective containers.
The affected product is distributed nationwide. The specific lot numbers involved are #224161, 224546, and 224547, all with an expiration date of 12/19. The product is distributed by Millennium Pharmaceuticals, Inc., located in Cambridge, MA.
Healthcare providers and patients should check their inventory for these specific lot numbers and discontinue use if found. The company estimates that 4% of the product may be recovered.
The recalled product
- Product
- 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, Distribu
- Manufacturer
- Millennium Pharmaceuticals Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 154,372
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers # 224161
- 224546 and 224547
- Exp. 12/19
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12