CLASS II Drug recall · Reported 17 Dec 2014 · FDA Enforcement Report
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) bottle recalled by Pfizer
Pfizer is recalling Tikosyn (dofetilide) 125 mcg (0.125 mg), a) bottle (. The recall was initiated on 3 Dec 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0292-2015
- FDA event ID
- 69724
- Recalling firm
- Pfizer, New York, NY
- Brand
- Tikosyn
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2014
- FDA classified
- 9 Dec 2014
- Reported
- 17 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 3 Dec 2014 | Recall initiated by company | |
| 9 Dec 2014 | Classified by FDA | +6 days |
| 17 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Product as listed by the FDA
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.
Where it was distributed
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Which lots are affected?
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Where was it sold?
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Dofetilide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dofetilide Capsules 500 mcg (0.5mg) recalledDofetilide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Dofetilide Capsules, 500 mcg (0.5 mg) recalled | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Dofetilide Capsules, 125 mcg (0.125 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Dofetilide Capsules 500 mcg (0.5 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Dofetilide Capsules 250 mcg (0.25 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |