Anticonvulsant Tablets Recalled

Amneal Pharmaceuticals of New York is recalling 4309 bottles of divalproex sodium extended-release tablets, 250 mg, because samples failed to meet dissolution specifications, according to the August 31, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects tablets packaged in 100-count bottles (NDC 65162-755-10) from lot AR210705 (Exp. 4/24). The tablets were manufactured by Amneal Pharmaceuticals in India and distributed throughout the United States by Amneal Pharmaceuticals, Bridgewater, NJ.

Amneal Pharmaceuticals of New York voluntarily initiated the recall July 27, 2022. The FDA designated the recall Class II on August 19, 2022. According to the recall classification, use of affected tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Divalproex sodium is a prescription medication used to treat seizure disorders, the manic phase of bipolar disorder, and to prevent migraine headaches.