Epilepsy Medication Recalled

Sun Pharmaceutical Industries Inc is recalling nearly 9000 bottles of tiagabine hydrochloride tablets for failing to meet impurity specifications during testing, according to the July 19, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects tiagabine hydrochloride tablets, 2 mg, 30-count bottles (NDC 62756-200-83), from lot HAC3339A (Exp 7/23). The drug was manufactured by Sun Pharmaceutical Industries Ltd, Gujarat, India, and distributed by Sun Pharmaceutical Industries, Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall July 10, 2023, and the FDA designated it Class II the following day. The classification suggests use of the affected medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Tiagabine hydrochloride is a prescription antiepilepsy drug indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.