Tikosyn (Pfizer) – Capsule Damage (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lot # a) H79652, Exp. 10/15, b) H79653, Exp. 10/15
Products Sold
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Pfizer Inc. is recalling Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle ( due to Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026