Class II · ModerateActive recall
Bortezomib for Injection 3.5mg/Vial
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Sterility Assurance
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Somerset Therapeutics, LLC., Somerset, NJ 08873 |
| NDC | 70069-0836-01 |
Show the full FDA record
| Full product label | Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 |
| Recalling firm | Reliance Life Sciences Private Limited |
| Distribution | Nationwide in the USA |
| Quantity | 11,400 vials |
| Recall initiated | 2026-06-24 |
| Report date | 2026-07-15 |
| Recall completed | — |
| Recall number | D-0673-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Navi Mumbai N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.