FDA recall D-0758-2026

Product

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

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-07-06

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockville, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0758-2026