Anticonvulsant Tablets Recalled

Amneal Pharmaceuticals of New York is recalling 21,452 bottles of divalproex sodium extended-release tablets because samples failed to meet dissolution specifications, according to the April 3, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles of divalproex sodium extended-release tablets, 250 mg (NDC 65162-755-10), from lots AR210704, AR210706, AR210707, AR210708, and AR210709 (Exp. 4/24). The tablets were distributed throughout the United States.

Amneal Pharmaceuticals of New York voluntarily initiated the recall December 26, 2023. On March 27, 2024, the FDA designated the recall a Class II. Per the classification, use of the recalled tablets could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Divalproex sodium is a prescription anticonvulsant used in the treatment of mania, epilepsy, and migraine.