Seizure Drug Recalled

Unichem Pharmaceuticals USA Inc is recalling 1284 bottles of topiramate because of tablet discoloration, according to the December 1, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 50-mg topiramate tablets in 500-count bottles (NDC 29300-116-05) from lot ZTPM20044 (Exp. 9/30/22). The tablets were manufactured by Unichem Laboratories, Ghaziabad, India, for Unichem Pharmaceuticals USA, East Brunswick, NJ, and were distributed throughout the United States.

Unichem Pharmaceuticals USA initiated the recall October 25, 2021. On November 19, 2021, the FDA designated the recall Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.

Topiramate is a prescription medication used alone or with other medications to prevent and control seizures. It is also used to prevent migraine headaches.