Rufinamide recalls

Rufinamide products have been recalled 3 times, most recently on 16 Apr 2025. The recalling company is usually Aurobindo Pharma USA. The most common reason is manufacturing (cgmp) deviations.

Total recalls3since 2023

Last 12 months0reported

Class I00% of total

Ongoing1latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why rufinamide is recalled

Manufacturing (CGMP) Deviations3100%

Companies

By year

2025133%
2023267%

Ongoing rufinamide recalls

1 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Rufinamide Tablets 200mg recalled by Glenmark PharmaceuticalsRufinamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide

All rufinamide recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Rufinamide Tablets 200mg recalled by Glenmark PharmaceuticalsRufinamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
30 Aug 2023Drug	CLASS II	Rufinamide Tablets, USP 200 mg recalled by Aurobindo Pharma USARufinamide	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
30 Aug 2023Drug	CLASS II	Rufinamide Tablets, USP 400 mg recalled by Aurobindo Pharma USARufinamide	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.