FDAFDA recall D-0673-2026 · Jul 15, 2026
Reliance Life Sciences Private Limited: Bortezomib for Injection 3 recall
Recall found
Product
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 for recall
Lack of Sterility Assurance
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
- Quantity
- 11,400 vials
- Distribution
- Nationwide in the USA
- Recalling firm
- Reliance Life Sciences Private Limited, Navi Mumbai, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-24
Source: openFDA enforcement record D-0673-2026 · search recall number D-0673-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.