FDA recall D-0833-2026

Product

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.

Reason for recall

Failed dissolution specifications.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-08-31

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockville, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0833-2026