Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
Is Azacitidine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Azacitidine (9 total). Check the affected lots below.
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azacitidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Azacitidine recalls in 2026
1 initiated in 2026, 9 in total — newest first
Class III · Low risk
Azacitidine for Injection
Subpotent Drug
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.
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Azacitidine 125 Mg / 5 Ml Sub-Q Syringe
Lack of Assurance of Sterility
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