FDAClass II · Drug · Recalled July 15, 2026

Bortezomib for Injection 3 recall — Reliance Life Sciences Private Limited

Hazard: Lack of Sterility Assurance

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0673-2026
Brand: Reliance Life Sciences Private
Classification: Class II
Units affected: 11,400 vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Bortezomib for Injection 3

Companies & origin

Recalling firm location: Navi Mumbai, N/A, India
Firm address: Ttc Area Of Midc, R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Distribution: Nationwide in the USA
Firm notified the public via: Letter
FDA event ID: 99312
Recall initiated: June 24, 2026
FDA classified: July 8, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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