Bortezomib for Injection 3.5mg/Vial recall (Reliance Life Sciences Private Limited)
DrugClass IIOngoing
Summary: Reliance Life Sciences Private Limited is recalling 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. Reason: Lack of Sterility Assurance.
What is being recalled
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
Why
Lack of Sterility Assurance
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0673-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 24, 2026 |
| Reported | July 15, 2026 |
| Company | Reliance Life Sciences Private Limited |
| Company location | Navi Mumbai, N/A, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11,400 vials |
More recalls from Reliance Life Sciences Private Limited · all drug recalls · recalls from June 2026