FDAClass II · Drug · Recalled July 15, 2026
Azacitidine for Injection 100mg/Vial 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-0674-2026
- Brand
- Reliance Life Sciences Private
- Classification
- Class II
- Units affected
- 8,001 vials
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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
Affected products
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: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
- 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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