FDA WARNING_LETTER - Nova Vascular LLC dba NOVARX - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to Nova Vascular LLC, doing business as NOVARX, following a March 2026 review of the company"s website. The review identified significant violations of the Federal Food, Drug, and Cosmetic Act regarding the marketing of compounded semaglutide and tirzepatide products. The FDA found that NOVARX engaged in misbranding by making false and misleading claims. Key violations included labeling drug products to suggest NOVARX was the manufacturer when it was not, and claiming that their products contain the same active ingredients as FDA-approved drugs like Ozempic. This falsely implies that the compounded versions have undergone the same safety and efficacy evaluations as approved medications. Furthermore, the company incorrectly described its sourcing facilities as "FDA Approved Pharmacies," a designation that does not exist under federal law. The FDA emphasized that compounded drugs are not FDA-approved and do not undergo premarket review. NOVARX is required to respond within 15 business days with a detailed plan to correct these violations, including identifying the actual drug producers and removing misleading website claims. Failure to implement sustained corrective measures may result in legal action, including product seizures or injunctions.