Tikosyn — Class II drug recall D-0292-2015
Terminated recall by Pfizer Inc., reported 2014-12-17. Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broke
| Recall number | D-0292-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2014-12-03 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2016-09-27 |
| Quantity | 31,569 hdpe |
| Reason classes | packaging |
| NDC | 00069-5800, 00069-5800-43, 00069-5800-60, 00069-5800-61, 00069-5810, 00069-5810-43, 00069-5810-60, 00069-5810-61, 00069-5820, 00069-5820-43, 00069-5820-60, 00069-5820-61 |
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.
Reason for recall
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0292-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.