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Class II · ModerateRecall completed

Rufinamide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: RB2023001A, Exp 02/2025
Where it was soldUSA nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

cGMP deviations: Batch was released prior to approval.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameRUFINAMIDE
Generic nameRUFINAMIDE
Active ingredient(s)RUFINAMIDE
Distributed by / forAurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC59651-616-08
Show the full FDA record
Full product labelRufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
Recalling firmAurobindo Pharma USA Inc.
DistributionUSA nationwide
Quantity48 bottles
Recall initiated2023-07-21
Report date2023-08-30
Recall completed2024-02-26
Recall numberD-1087-2023
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.