FDA recall D-0673-2026

Reliance Life Sciences Private Limited · Class II · drug

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2026-06-24
Report date: 2026-07-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Navi Mumbai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0673-2026