Epilepsy, Migraine Drug Recalled

Azurity Pharmaceuticals Inc. is recalling 2220 bottles of Eprontia oral solution. According to the January 10, 2024, US Food and Drug Administration (FDA) Enforcement Report, samples of the drug tested out of specification for an impurity during routine 18-month testing.

The recall affects Eprontia (topiramate) oral solution, 25 mg/mL, in 473-mL bottles (NDC 52652-9001-1), from lot MB22020B (Exp. 12/27/23). The product was manufactured for Azurity Pharmaceuticals, Woburn, Massachusetts, and distributed throughout the United States.

Azurity Pharmaceuticals voluntarily initiated the recall December 8, 2023. The FDA designated the recall Class III on January 2, 2024. Per the classification, use of the affected solution is not likely to cause harm.

Eprontia is a prescription oral solution indicated for the treatment of epilepsy, Lennox-Gastaut syndrome, and migraine.