Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solution
Summary
The FDA issued a recall for Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, M by Supernus Pharmaceuticals, Inc.. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
N/A
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
Lot/Code Info: Lot # 2075801, Exp Date: 31-Oct-2029.
Quantity Affected: N/A
Reason for Recall
Failed Dissolution Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-06
Company
Rockville, MD
Context & Analysis
This is a unclassified recall.
This was one of 48 drug recalls issued in the same week, part of 59 drug-related FDA actions this month.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Supernus Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Supernus Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Supernus Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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