Anticonvulsant Capsules Recalled

Amneal Pharmaceuticals of New York is recalling 9056 bottles of extended phenytoin sodium capsules distributed in three states. According to the June 21, 2023, US Food and Drug Administration (FDA) Enforcement Report, dissolution testing of the product showed results above specification.

The recall affects extended phenytoin sodium capsules, 100 mg, 100-capsule bottles (NDC 65162-212-10), from lot HL00721A (Exp 12/23). The product was distributed in Louisiana, Pennsylvania, and Ohio by Amneal Pharmaceuticals, Bridgewater, New Jersey.

Amneal Pharmaceuticals of New York voluntarily initiated the recall May 30, 2023. The FDA designated the recall Class II on June 15, 2023. The classification suggests use of the affected capsules may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Extended phenytoin sodium capsules are available with a prescription for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures, and for the prevention and treatment of seizures associated with neurosurgery.