RecallRadar

FDA Drug recall D-0112-2017

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winche…

On 2016-10-26 the FDA classified a Class II recall of Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winche… by Supernus Pharmaceuticals, citing superpotent Drug: Failure of assay specifications in the capsule.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0112-2017
ClassificationClass II
Statusterminated
Initiated2016-07-12
Published2016-10-26
Last updated2026-09-13 11:51 UTC
CompanySupernus Pharmaceuticals
DistributionUS

Product

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15

Reason

Superpotent Drug: Failure of assay specifications in the capsule.

Identifiers

ndc17772-102-70
ndc17772-102-01
ndc17772-102-30
ndc17772-102-15
ndc17772-102-10
ndc17772-102-12
ndc17772-102-07
ndc17772-103-70
ndc17772-103-01
ndc17772-103-30
ndc17772-103-15
ndc17772-103-10
ndc17772-103-12
ndc17772-103-07
ndc17772-104-70
ndc17772-104-01
ndc17772-104-30
ndc17772-104-15
ndc17772-104-12
ndc17772-104-10
ndc17772-104-07
ndc17772-101-70
ndc17772-101-01
ndc17772-101-30
ndc17772-101-15
ndc17772-101-10
ndc17772-101-12
ndc17772-101-07
code_infoLot # 426636, Exp 4/22/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.