Recall
FDAHealthJune 24, 2026

Reliance Life Sciences Private Limited — Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset,

⚠️ Lack of Sterility Assurance

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 24, 2026

Nationwide in the USA

What's affected?

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
Lot code
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028

Additional details

Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 11,400 vials.

View original FDA notice →

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