United Therapeutics Corp.

FDA recalling firm · 3 enforcement events · 3 product records · 2014–2018 · NC

United Therapeutics Corp. has 3 FDA enforcement events on this register (3 product records) between 2014 and 2018: 3 drug; the busiest year was 2014 with 1.

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

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

Initiated	Product (first record)	Type	Class	Records	Status
14 Aug 2018	Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709	Drug	Class III	1	Terminated
11 Sep 2017	TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601	Drug	Class II	1	Terminated
28 Mar 2014	Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709	Drug	Class II	1	Terminated

By type and class

Drug3

Class II2

Class III1

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

Events by year

Enforcement events for United Therapeutics Corp. by year initiated.

Questions and answers

How many FDA recalls has United Therapeutics Corp. had?

3 enforcement events (3 product records) on this register, 2014–2018: 3 drug.

Are any United Therapeutics Corp. recalls ongoing?

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

What class are United Therapeutics Corp. recalls?

2 Class II, 1 Class III. 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.