FDA WARNING_LETTER - Ezra Holdco LLC dba Ezra - May 01, 2026

On June 8, 2026, the FDA issued a warning letter to Ezra Holdco LLC, doing business as Ezra, following a review of the company’s website conducted in May 2026. The regulatory review focused on the marketing and sale of compounded semaglutide and tirzepatide products. The FDA identified significant violations related to false and misleading claims, which categorize these drug products as misbranded under the Federal Food, Drug, and Cosmetic Act. Specifically, the FDA found that Ezra’s website displayed product labels identifying the company as the manufacturer or compounder when, in fact, it is not the entity producing the drugs. This lack of transparency regarding the source of the compounded medication violates federal regulations intended to protect public health from unsafe or ineffective drug products. The regulatory framework cited includes sections of the Act that prohibit the introduction of misbranded drugs into interstate commerce and require accurate advertising and labeling for compounded medications. To resolve these issues, Ezra is required to investigate the root causes of the violations and implement corrective actions to ensure future compliance. The company must submit a written response within 15 business days detailing its progress. This response must identify the actual entities compounding the drugs, provide representative samples of corrected labels, and prove that misleading website claims have been removed or modified. Failure to address these concerns promptly may result in legal action, including product seizures or injunctions.