Roen Health, Inc. dba RoenRx
FDA issued a warning letter to Roen Health, Inc. dba RoenRx (New York, NY) after a March 2026 review of its website found false or misleading claims about compounded semaglutide products. The website falsely implied FDA approval by associating compounded semaglutide with FDA-approved brand names Wegovy and Ozempic, and also misidentified RoenRx as the compounder on product labels. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.
Flagged claims (4)
Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….
RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….
Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.
The compounded semaglutide products displayed on your website identify "RoenRx" on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not.
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker