Information
Supernus Pharmaceuticals Recalls Trokendi XR
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0758-2026Drug / Pharmaceutical
Supernus Pharmaceuticals Recalls Trokendi XR
Supernus Pharmaceuticals, Inc. · Class III — Regulatory
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.
Reason for Recall
Failed Dissolution Specifications
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Supernus Pharmaceuticals, Inc. initiated a Class III recall of a pharmaceutical product on July 6, 2026 affecting 15,853 bottles. Failed Dissolution Specifications. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed in US Nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.