FDA WARNING_LETTER - Bioverse, Inc. dba Bioverse - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Bioverse, Inc. (doing business as Bioverse), a New York-based company. The warning follows an August 2025 review of the company"s website, which revealed the sale of compounded drug products containing semaglutide and tirzepatide. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the company marketed its compounded products using claims that they contain the "same active ingredient" as well-known FDA-approved medications such as Ozempic, Wegovy, Mounjaro, and Zepbound. The FDA determined these statements are false or misleading because they suggest the compounded versions are equivalent to the approved brand-name drugs. Since compounded drugs do not undergo the same FDA approval process, such comparisons misbrand the products under sections 502(a) and 502(bb) of the FDCA. Distributing these misbranded drugs across state lines is a prohibited act. To resolve these issues, the FDA requires Bioverse to take immediate corrective action, including removing the misleading claims from its marketing materials. The company must provide a written response within 15 working days detailing the specific steps taken to address the violations and prevent their recurrence. Failure to comply could lead to serious legal consequences, such as product seizures or court-ordered injunctions.