Tyvaso — Class II drug recall D-1423-2014
Terminated recall by United Therapeutics Corp., reported 2014-07-16, distributed in TX. Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Sy
| Recall number | D-1423-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Therapeutics Corp., Research Triangle Park, NC, United States |
| Recall initiated | 2014-03-28 |
| Classified | 2014-07-07 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2014-10-24 |
| Distributed | TX |
| Quantity | 188 units |
| Reason classes | software |
| Lot numbers | TD-100 |
| Serial numbers | 1894ML, 1895ML, 1896, 1897ML, 1898ML, 23103954, 23103976, 23103995, 23104000, 23104006, 23104015, 23104016, 23104017, 23104018, TD-100 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1423-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.