Rufinamide recalls

The FDA has published 4 recalls involving Rufinamide since 2021. The latest was reported on 16 Apr 2025. Most were for manufacturing (cgmp) deviations. Aurobindo Pharma USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2021

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 4 100%Class III 0 0%

Why rufinamide is recalled

Manufacturing (CGMP) Deviations375%
Foreign Material125%

Companies

Brands

Rufinamide375%
Banzel125%

By year

2025125%
2023250%
2021125%

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

4 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
2 Jun 2021Drug	CLASS II	Banzel (rufinamide) tablets 200 mg recalled by Cardinal HealthBanzel	Cardinal Health	Foreign Material	FL, GA, SC

Should you stop taking Rufinamide?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.