Clover Meds LLC dba Clover Meds
FDA issued a warning letter to Clover Meds LLC dba Clover Meds (Sarasota, FL) in June 2026 following a review of their website, which markets compounded semaglutide and tirzepatide products. The agency found two false or misleading representations: product labels bearing the 'Clover Meds' name implied the company was the compounder when it was not, and the website falsely described sourcing facilities as 'FDA-licensed,' a designation FDA does not grant to compounding pharmacies or outsourcing facilities. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), and FDA warned that failure to correct violations could result in seizure or injunction.
Flagged claims (2)
FDA-licensed Facilities
The compounded semaglutide and tirzepatide products displayed on your website identify "Clover Meds" on the pictured label, suggesting Clover Meds 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?
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