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Drug Class III · low Ongoing

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.

Failed Dissolution Specifications

Recalling firmSupernus Pharmaceuticals, Inc.
ReasonFailed Dissolution Specifications
Risk classClass III (Class III · low)
StatusOngoing
Report dateJul 29, 2026
InitiatedJul 6, 2026
RegionMD, United States
DistributionUS Nationwide.
Quantity15,853 bottles
Code/LotLot # 2075801, Exp Date: 31-Oct-2029.
TypeVoluntary: Firm initiated
Recall numberD-0758-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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