Topiramate Capsules Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for Trokendi (topiramate) extended-release capsules, 50 mg. The affected batch has been identified as Lot 2145283 (expires March 2030), containing 11 304 bottles
• The recall was initiated by Supernus Pharmaceuticals, Inc due to failed dissolution specifications, a quality issue that is not likely to cause adverse health consequences.
• Topiramate is used to treat seizures and prevent migraines.

The FDA has issued a Class III recall for Trokendi (topiramate) extended-release capsules, 50 mg, affecting 11 304 bottles. This product is manufactured by Catalent Pharma Solutions in Kentucky and is being recalled by Supernus Pharmaceuticals, Inc based in Rockville, Maryland. The recall was initiated on August 31, 2026, and received a Class III classification on September 3, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated due to the product’s failure to meet dissolution specifications. This deficiency affects Lot 2145283, which will expire in March 2030. Supernus Pharmaceuticals has not sent out a public notice, and no press release has been issued for this recall.

Topiramate is used to treat certain types of seizures. It can also be used to prevent migraines. Pharmacists should identify and quarantine Lot 2145283, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 2, 2026. Accessed September 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222437