# FDA recall D-0112-2017

> **Supernus Pharmaceuticals, Inc.** · Class II · drug recall initiated 2016-07-12.

## 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 for recall

Superpotent Drug: Failure of assay specifications in the capsule.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0112-2017
- **Recalling firm:** Supernus Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-07-12
- **Report date:** 2016-10-26
- **Termination date:** 2019-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockville, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2017

## Citation

> AI Analytics. FDA recall D-0112-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0112-2017. Source: US FDA. Licensed CC0.

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