FDA Drug recall D-0292-2015
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, Manufacture…
- FDA Drug
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of 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, Manufacture… by Pfizer, citing failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0292-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | n/a |
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
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Identifiers
| ndc | 0069-5800-61 |
|---|---|
| ndc | 0069-5800-60 |
| ndc | 0069-5800-43 |
| ndc | 0069-5810-61 |
| ndc | 0069-5810-60 |
| ndc | 0069-5810-43 |
| ndc | 0069-5820-61 |
| ndc | 0069-5820-60 |
| ndc | 0069-5820-43 |
| code_info | Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15 |
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-0292-2015%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.