Sun Pharmaceutical Industries Inc. has voluntarily recalled 360 bottles of Dofetilide (500 mcg/0.5 mg) capsules because the medication failed content uniformity testing. The recall affects 60-count bottles of this prescription heart medication. While no injuries have been reported, failing these tests means the amount of active ingredient in each capsule may be inconsistent.
Inconsistent levels of medication in heart rhythm drugs like Dofetilide could cause a patient to receive more or less than their prescribed dose, which may reduce effectiveness or lead to safety concerns.
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Rx Only; Manufactured by Sun Pharmaceutical Industries Limited in India.
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Sources: FDA iRES · Raw API Response
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