Class II · Moderate risk Terminated
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-713-08
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0323-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Rufinamide recalls
See all
Class II · Moderate risk Terminated
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Terminated
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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