Ezra Holdco LLC dba Ezra
FDA issued a warning letter to Ezra Holdco LLC dba Ezra (joinezra.com) in June 2026 for false or misleading representations on its website concerning compounded semaglutide and tirzepatide products. The core violation is that product labels displayed on the website identify 'Ezra' as the compounder when Ezra is not actually the manufacturer, constituting misbranding under FD&C Act sections 502(a) and 502(bb). FDA found these practices result in misbranded drug products being introduced into interstate commerce in violation of section 301(a). Ezra was required to respond within 15 business days with corrective steps, including identifying actual compounders, providing sample labeling, and removing or modifying false or misleading website claims.
Flagged claims (1)
The compounded semaglutide and tirzepatide products displayed on your website identify "Ezra" on the pictured label, suggesting Ezra is the compounder of those drugs when in fact it is not.
Required actions (2)
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)].
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