FDA Drugs recall ·
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial… recall
- Recall number
- D-0673-2026
- Date
- (initiated June 24, 2026)
- Company / brand
- Reliance Life Sciences Private Limited
Ttc Area Of Midc, Navi Mumbai, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,400 vials
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Sterility Assurance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0673-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.