Anticonvulsant Recalled

Citing deviations from Current Good Manufacturing Practice regulations, Glenmark Pharmaceuticals Inc is recalling numerous lots of zonisamide capsules. The recall was included in the September 29, 2021, US Food and Drug Administration (FDA) Enforcement Report.

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

• 50-mg zonisamide capsules in 100-count bottles (NDC 68462-129-01) from lots 29190043 (Exp. 5/31/22), 29190044 (Exp. 5/31/22), and 29190045 (Exp. 5/31/22);
• 100-mg zonisamide capsules in 100-count bottles (NDC 68462-130-01) from lots 29200014 (Exp. 2/28/23), 29200015 (Exp. 3/31/23), 29200016 (Exp. 3/31/23), 29200030 (Exp. 5/31/23), 29200031 (Exp. 5/31/23), 29200032 (Exp. 5/31/23), 29200033 (Exp. 6/30/23), 29200037 (Exp. 6/30/23), 29200038 (Exp. 6/30/23), 29200039 (Exp. 7/31/23), 29200041 (Exp. 7/31/23), 29200042 (Exp. 7/31/23), 29200048 (Exp. 8/31/23), 29200049 (Exp. 8/31/23), 29200050 (Exp. 8/31/23), 29200072 (Exp. 11/30/23), 29200073 (Exp. 11/30/23), 29200074 (Exp. 11/30/23), 29200075 (Exp. 11/30/23), and 29200076 (Exp. 11/30/23); and
• 100-mg zonisamide capsules in 500-count bottles (NDC 68462-130-05) from lots 29200014 (Exp. 2/28/23), 29200015 (Exp. 3/31/23), and 29200016 (Exp. 3/31/23).

Glenmark Pharmaceuticals voluntarily initiated the recall August 27, 2021. On September 21, 2021, the FDA designated the recall Class II, which warns use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Zonisamide is a prescription anticonvulsant used with other medications to prevent and control seizures.