Recall Register

Food, drugs, devices › Firms

Supernus Pharmaceuticals, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2016–2026 · MD

Supernus Pharmaceuticals, Inc. has 3 FDA enforcement events on this register (3 product records) between 2016 and 2026: 3 drug; the busiest year was 2026 with 2.

0% of its events are Class I; the most common class is Class III (2). 2 events are listed as ongoing; the recalling firm's address is in MD.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
31 Aug 2026Trokendi 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.DrugClass III1Ongoing
6 Jul 2026Trokendi 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.DrugClass III1Ongoing
12 Jul 2016Trokendi 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 17772-102-15DrugClass II1Terminated

By type and class

Drug3
Class III2
Class II1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Supernus Pharmaceuticals, Inc. by year initiated.

Questions and answers

How many FDA recalls has Supernus Pharmaceuticals, Inc. had?

3 enforcement events (3 product records) on this register, 2016–2026: 3 drug.

Are any Supernus Pharmaceuticals, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Supernus Pharmaceuticals, Inc. recalls?

2 Class III, 1 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.