Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Is Decitabine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Decitabine (3 total). Check the affected lots below.
Most common reason: Impurity / degradation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Decitabine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Decitabine recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
DECITABINE 40 MG / 100 ml NS IVPB
Lack of Assurance of Sterility
Class III · Low risk
Decitabine for Injection
Failed impurities/degradation specifications: Failure to water content and impurity
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