Dofetilide recalls

The FDA has published 6 recalls involving Dofetilide since 2014. The latest was reported on 16 Aug 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 Aug 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 67%Class III 2 33%

Why dofetilide is recalled

Companies

Brands

Dofetilide467%
Tikosyn117%

By year

2023583%
2014117%

All dofetilide recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
16 Aug 2023Drug	CLASS III	Dofetilide Capsules 500 mcg 5mg) recalledDofetilide	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS III	Dofetilide Capsules, 500 mcg 5 mg) recalled	Sun Pharmaceutical Industries	Other	Nationwide
8 Mar 2023Drug	CLASS II	Dofetilide Capsules, 125 mcg 125 mg) recalled by Accord HealthcareDofetilide	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Dofetilide Capsules 500 mcg 5 mg) recalled by Accord HealthcareDofetilide	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Dofetilide Capsules 250 mcg 25 mg) recalled by Accord HealthcareDofetilide	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
17 Dec 2014Drug	CLASS II	Tikosyn (dofetilide) 125 mcg 125 mg), a) bottle recalled by PfizerTikosyn	Pfizer	Other	NY

Should you stop taking Dofetilide?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.