Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tikosyn (dofetilide) 125 mcg (0.125 mg) Recalled by Pfizer Inc. Due to Failed Tablet/Capsule Specifications: Product being recalled due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Inc. directly.
Affected Products
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.
Quantity: 31,569 HDPE Bottles
Why Was This Recalled?
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Where Was This Sold?
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
About Pfizer Inc.
Pfizer Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report