Reliance Life Sciences Private Limited: Azacitidine For Injection 100mg/vial, 1

Azacitidine for Injection Recall Summary Reliance Life Sciences is recalling Azacitidine for Injection 100mg/Vial (NDC 70069-0857-01), manufactured for Somerset Therapeutics, due to lack of sterility assurance, meaning the product may not meet required sterility standards. The affected vials were distributed nationwide across all U.S. states and the District of Columbia. This is a Class II recall, which indicates a potential serious health risk.

Recalling firm

Reliance Life Sciences Private Limited

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

Lack of Sterility Assurance

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-24

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/eaa6b8c4-c363-463e-9eb8-e369da0d0db5