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CLASS II · ModerateFDA

Reliance Life Sciences Private Limited recalls Bortezomib for Injection 3.5mg/Vial

📅 Jun 24, 2026 · 📍 Nationwide
Recalling company
Reliance Life Sciences Private Limited
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
Lack of Sterility Assurance
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 24, 2026
Reported
Jul 15, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
11,400 vials
Lot / codes
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Company location
Navi Mumbai, N/A
Recall type
Voluntary: Firm initiated
Recall number
D-0673-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0673-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.