FDA Drug Recalls

Recalls / Active ingredient / Rufinamide

Rufinamide

4 FDA drug recalls involving the active ingredient “Rufinamide.

DateClassProductFirm
2025-03-13Class IIRufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithamGlenmark Pharmaceuticals Inc., USA
2023-07-21Class IIRufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Aurobindo Pharma USA Inc.
2023-07-21Class IIRufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Aurobindo Pharma USA Inc.
2021-03-15Class IIBanzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. MarketCardinal Health Inc.