Ready Med
FDA issued a warning letter to Ready Med (Clearwater, FL) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The violations included falsely implying Ready Med was the compounder of the drugs, misrepresenting compounded products as equivalent to FDA-approved branded drugs (Mounjaro, Zepbound, Ozempic, Rybelsus), and falsely describing the compounding facility as 'FDA licensed.' These representations caused the products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act, and FDA warned that failure to correct violations could result in seizure and injunction.
Flagged claims (3)
The same active ingredient in Mounjaro® and Zepbound™
The same active ingredient in Ozempic® and Rybelsus®
FDA licensed compounding facility
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?
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