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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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 →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighVital Care Compounder Recalls Methylcobalamin Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-06
- ModerateSandoz Recalls Infuvite Pediatric Injection Due to Defective Container Crimping
FDA (Drugs) · 2020-05-13
- SevereCustomceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2019-05-08
- HighCompounded Semaglutide Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-04-26
- SevereMidazolam Injectable Recalled for Silicone Particulate Matter Contamination
FDA (Drugs) · 2023-11-29
- ModerateFDA recalls Verapamil Hydrochloride injectable due to cross contamination
FDA (Drugs) · 2024-07-17