Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Is Dofetilide recalled?
Not under an active recall.
Dofetilide was recalled 7 times in the past — all now closed. Most recent: Jul 18, 2023.
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dofetilide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dofetilide recalls on record
none so far in 2026; 7 on record, newest first
Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class II · Moderate risk
Dofetilide Capsules 500 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules 250 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tikosyn (dofetilide)
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Class II · Moderate risk
Tikosyn¿ (dofetilide)
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
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