Class III · Low risk
Azacitidine for Injection
Subpotent Drug
Azacitidine for Injection 100mg/Vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 NDC
70069-0857-01
Compare with the code on your package — it is the most precise check available.
Drug: Azacitidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Azacitidine NDC 70069-0857 |
100 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous|subcutaneous |
Somerset Therapeutics LLC | Rx |
- Recalling firm
- Reliance Life Sciences Private Limited
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0674-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Azacitidine recalls
See all
Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk
Azacitidine
Failed stability specifications
Class III · Low risk
Azacitidine
Failed stability specifications
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Other recalls by Reliance Life Sciences Private Limited
All 2026 recalls
Class II · Moderate risk
Bortezomib for Injection 3.5mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 500mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 100mg/Vial
Lack of Sterility Assurance
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