Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Is Treprostinil recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Treprostinil (4 total). Check the affected lots below.
Most common reason: Packaging defect (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Treprostinil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Treprostinil recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class II · Moderate risk
Tyvaso (treprostinil)
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.
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