RecallRadar

FDA Drug recall D-0673-2026

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeuti…

On 2026-07-15 the FDA classified a Class II recall of Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeuti… by Reliance Life Sciences Private, citing lack of Sterility Assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0673-2026
ClassificationClass II
Statusongoing
Initiated2026-06-24
Published2026-07-15
Last updated2026-09-13 11:52 UTC
CompanyReliance Life Sciences Private
DistributionUS

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0673-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.