Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tyvaso (treprostinil) Inhalation Solution Recalled by United Therapeutics Corp. Due to Defective Delivery System: United Therapeutics is voluntarily recalling...

Date: March 28, 2014
Company: United Therapeutics Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact United Therapeutics Corp. directly.

Affected Products

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

Quantity: 188 Units

Why Was This Recalled?

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About United Therapeutics Corp.

United Therapeutics Corp. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report