Seizure Medication Recalled

Glenmark Pharmaceuticals Inc is recalling 4 lots of zonisamide capsules because of deviations from Current Good Manufacturing Practice regulations, according to the May 4, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products, which were manufactured by Glenmark Pharmaceuticals, Monroe, NC, for Glenmark Pharmaceuticals, Mahwah, NJ, and distributed throughout the United States:

• zonisamide capsules, 25 mg, packaged in 100-count bottles (NDC 68462-128-01), from lot 29200052 (Exp. 4/30/23);
• zonisamide capsules, 50 mg, packaged in 100-count bottles (NDC 68462-129-01), from lot 29200064 (Exp. 5/31/23);
• zonisamide capsules, 100 mg, packaged in 100-count bottles (NDC 68462-130-01), from lot 29200053 (Exp. 4/30/23); and
• zonisamide capsules, 100 mg, packaged in 500-count bottles (NDC 68462-130-05), from lot 29200054 (Exp. 4/30/23).

Glenmark Pharmaceuticals voluntarily initiated the recall April 25, 2022. The FDA designated the recall Class II on April 27, 2022, signaling use of the affected medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Zonisamide is a prescription anticonvulsant medication used as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.