FDA WARNING_LETTER - Nexus Health Solutions LLC dba Harper Meds - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to Nexus Health Solutions LLC, doing business as Harper Meds, following a March 2026 review of the company’s website. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act regarding the marketing of compounded drug products, specifically semaglutide and tirzepatide. The FDA determined that the company’s promotional materials were false or misleading, resulting in the distribution of misbranded drugs.

Key issues included the use of product labels that incorrectly implied Harper Meds was the actual manufacturer. Furthermore, the company claimed its products contained the "same active ingredient" as approved medications like Ozempic and Wegovy, which deceptively suggested that these compounded versions had been evaluated by the FDA for safety and effectiveness. The website also inaccurately described its sourcing facilities as "FDA-licensed" or "FDA-approved," designations that do not exist for compounding pharmacies.

To resolve these violations, Harper Meds must submit a written response within 15 business days detailing the corrective actions taken. Required actions include identifying the true manufacturers of the drugs, providing sample labeling, and removing all misleading claims from their website. The company is responsible for investigating the root causes of these failures and ensuring long-term compliance to avoid potential legal action, such as product seizures or injunctions.