FDA warning letter · #716821
Curex: What the FDA Letter Means for What You Pay
Primary source
Read the original letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curex-716821-09092025
What FDA cited
Read the full letter →Quoted verbatim from the FDA letter dated
“This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://getcurex.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.”
“The following claims concerning compounded semaglutide and tirzepatide products appear on your website: "Clinically proven success" "Clinically proven weight loss treatments" "The same active ingredients as Ozempic or Mounjaro" "Prescription weight loss with the same active ingredients as Mounjaro & Zepbound." "While we don't prescribe Ozempic, Wegovy, Zepbound, or Mounjaro directly, we may prescribe treatments containing the same active ingredients."”
“Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Is Curex still operating?
getcurex.com returned a live storefront when we checked in August 2026 — the homepage now markets itself as "Allergy Care & GLP-1," still offering the compounded products named in the letter.
What this means for what you pay
Curex's flagged language explicitly disclaims prescribing the brand drugs directly, then pairs that disclaimer with "same active ingredients" — FDA read the combination as still implying FDA evaluation the compounded version hasn't had. The lesson for a reader comparing prices here isn't about safety; it's that a disclaimer sitting next to a brand-name comparison doesn't neutralize the comparison in FDA's view.
Has Curex responded?
As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Curex failed to respond.
Sources
Other letters in this index
View the full index →Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.