FDA Drug recall D-1253-2014
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc
- FDA Drug
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc by Pfizer, citing 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).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1253-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-08 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
Reason
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).
Identifiers
| code_info | H48496, H48497; Exp 05/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1253-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.