Antiarrhythmic Capsules Recalled

Sun Pharmaceutical Industries Inc is recalling 360 bottles of dofetilide capsules. According to the August 16, 2023, US Food and Drug Administration (FDA) Enforcement Report, testing yield out-of-specification results for content uniformity.

The recall affects dofetilide capsules, 500 mcg (0.5 mg), in 60-count bottles (NDC 47335-063-86), from lot DNE0217A (Exp 1/25). The capsules were manufactured by Sun Pharmaceutical Industries Limited, Dadra, India, and distributed by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall July 18, 2023. On August 7, 2023, the FDA designated it Class III, suggesting use of the recalled capsules is unlikely to cause harm.

Dofetilide is a prescription antiarrhythmic medication indicated for maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter, and for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.