Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solut
Summary
The FDA issued a Class III for Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only by Supernus Pharmaceuticals, Inc.. Reason: Failed dissolution specifications..
Details
Source
Drug Recall
External ID
D-0833-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
Product Description
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
Lot/Code Info: Lot# 2145283, Exp Date: 31-Mar-2030.
Quantity Affected: 11304 bottles
Reason for Recall
Failed dissolution specifications.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Rockville, MD
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Supernus Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III 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?
Supernus Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0833-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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