Dofetilide recalls

Dofetilide products have been recalled 4 times, most recently on 16 Aug 2023. The recalling company is usually Accord Healthcare. The most common reason is manufacturing (cgmp) deviations.

Total recalls4since 2023

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 3 75%Class III 1 25%

Why dofetilide is recalled

Manufacturing (CGMP) Deviations375%
Potency & Assay125%

Companies

Accord Healthcare375%
Sun Pharmaceutical Industries125%

By year

20234100%

All dofetilide recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
16 Aug 2023Drug	CLASS III	Dofetilide Capsules 500 mcg 5mg) recalledDofetilide	Sun Pharmaceutical Industries	Potency & Assay	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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.