Use cautionDrug recall · FDA · Published March 4, 2024
Par Sterile Products Recalls Treprostinil Injection Due to Particulate Matter Risk
Par Sterile Products recalls Treprostinil Injection 20 mg/20 mL vials due to potential particulate matter. This could cause serious complications during infusion. Consumers should contact the manufacturer for details.
“Par Sterile Products Recalls Treprostinil Injection Due to Particulate Matter Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32783-par-sterile-products-recalls-treprostinil-injection-due-to-particulate-matter. Based on FDA recall #D-0429-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0429-2024%22&limit=1).
Par Sterile Products LLC voluntarily recalled Treprostinil Injection due to the presence of particulate matter, according to the FDA. The Food and Drug Administration announced the Class I recall on March 4, 2024.
How to tell if you have it
Brand: Par Sterile Products
Product: Treprostinil Injection, 20 mg/20 mL (1 mg/mL)
NDC: 42023-206-01
Lot#: 57014
Expiration: 04/30/2024
The hazard
The recall addresses the presence of particulate matter in the drug product. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.
Context
GovInfoNow's records show Par Sterile Products LLC has issued three other recalls since April 28, 2017. On January 11, 2024, the company recalled Vasostrict Injection due to superpotent drug risk, and on November 9, 2021, it recalled Buprenorphine Injections because of crystallization risks. Other recent recalls of similar products include Sunny Pharmtech Cyclophosphamide Injection (July 17, 2026) and American Regent Papaverine HCl Injection (July 24, 2026).
How to tell if you have this one
Check the vial label for the product name, 'Treprostinil Injection, 20 mg/20 mL (1 mg/mL)'. Look for the lot number 57014 and expiration date 04/30/2024.
Brand
Par Sterile Products
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Details
Identify the lot number and expiration date on the vial label to confirm if it matches the recalled batch.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0429-2024 (March 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0429-2024 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.