FDA recall D-0674-2026

Product

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

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-0674-2026