Azacitidine for Injection 100mg/Vial — Class II drug recall D-0674-2026
Ongoing recall by Reliance Life Sciences Private Limited, reported 2026-07-15, distributed nationwide. Lack of Sterility Assurance
| Recall number | D-0674-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reliance Life Sciences Private Limited, Navi Mumbai, N/A, India |
| Recall initiated | 2026-06-24 |
| Classified | 2026-07-08 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 8,001 vials |
| Reason classes | sterility |
| NDC | 70069-0857-01 |
| Lot numbers | RAZM0425A, RAZM0525A, RAZM0725A, RAZM0825A, RAZM0925A, RAZM1125A, RAZM1225A, RAZM1425A, RAZM1525A, RAZM1625A, RAZM1725A, RAZM2025A |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0674-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.