United Therapeutics Corp. recalls TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit
United Therapeutics recalls TYVASO inhalation solution (treprostinil) with CGMP deviations. Affected units include specific model and lot numbers. Consumers should contact the company for details.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
United Therapeutics is recalling TYVASO inhalation solution due to manufacturing quality control issues. This recall affects specific model and lot numbers, and consumers should contact the company for instructions. Read more at govinfonow.com/recall/41257-united-therapeutics-recalls-tyvaso-inhalation-solution-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/41257-united-therapeutics-recalls-tyvaso-inhalation-solution-due-to-cgmp-deviations · Updated October 7, 2026 · FDA enforcement record: FDA #D-0083-2018
Cite this page
“United Therapeutics recalls TYVASO inhalation solution due to CGMP deviations.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41257-united-therapeutics-recalls-tyvaso-inhalation-solution-due-to-cgmp-deviations. Based on FDA recall #D-0083-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0083-2018%22&limit=1).
Why it’s dangerous
CGMP deviations refer to manufacturing quality control issues that could affect product safety and effectiveness. However, the specific risk to consumers is not clearly described in the recall notice.
Who’s affected
People with prescriptions for TYVASO inhalation solution (treprostinil) who received the affected model and lot numbers are likely affected. Those using the product for pulmonary arterial hypertension are at risk.
How to tell if you have this one
Check the product label for model number TD-100/A and lot numbers 2101152 (expiring 12/11/2017) or 2101195 (expiring 04/26/2019). The product is prescription-only and sold through healthcare providers.
- Brand
United Therapeutics- Category
Drug
What to do — step by step
Contact United Therapeutics
Reach out to United Therapeutics for specific instructions on how to handle the recalled product.
Questions people ask
Is this product safe to use?
The recall notice does not specify if the product is safe to use; it mentions CGMP deviations but does not detail the risk.
How can I check if my product is affected?
Check the product label for model number TD-100/A and lot numbers 2101152 (expiring 12/11/2017) or 2101195 (expiring 04/26/2019).
What should I do if I have the recalled product?
Contact United Therapeutics for specific instructions on how to handle the recalled product.
Contact United Therapeutics
We’ve drafted a message you can send United Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0083-2018 — United Therapeutics United Therapeutics Hello, I own a United Therapeutics that is covered by recall D-0083-2018 from United Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0083-2018 (September 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0083-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.