Azacitidine for Injection 100mg/Vial recall
FDA recall D-0674-2026 · initiated Jun 24, 2026
Reliance Life Sciences Private Limited recalled Azacitidine for Injection 100mg/Vial in Jun 2026 — an FDA Class II recall (D-0674-2026) because Lack of Sterility Assurance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Sterility Assurance
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,001 vials
Details
- 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
- Recalling company
- Reliance Life Sciences Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 24, 2026
- FDA report date
- Jul 15, 2026
Frequently asked
- Was Azacitidine for Injection 100mg/Vial recalled?
- Reliance Life Sciences Private Limited recalled Azacitidine for Injection 100mg/Vial in Jun 2026 — an FDA Class II recall (D-0674-2026) because Lack of Sterility Assurance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Azacitidine for Injection 100mg/Vial recalled?
- Per the FDA enforcement record, the reason for recall D-0674-2026 was: Lack of Sterility Assurance
- Is a recalled Azacitidine for Injection 100mg/Vial dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Azacitidine for Injection 100mg/Vial are affected?
- Distributed: Nationwide in the USA. The recall covers these 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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0674-2026.