FDA sends 25 warning letters to telehealth firms over compounded semaglutide and tirzepatide marketing

The FDA has sent 25 warning letters to telehealth companies over how they marketed compounded semaglutide and tirzepatide, saying the claims were false or misleading ^[1]. The letters were posted on the agency's website on June 16, 2026, and went out earlier in the month, according to Reuters ^[1].

Reuters named three recipients — Medica Weight Loss, Ready Med and Clover Meds — and said other companies also received letters but were not identified in its report ^[1]. A complete list of the 25 recipients has not been reported.

What the agency flagged

The letters describe several kinds of statements the FDA found problematic. Some companies said their compounded products came from FDA-approved pharmacies, or that the ingredients had been clinically studied ^[1]. Others told customers their compounded drugs were equivalent to approved GLP-1 medicines, or displayed the products in a way that indicated the company did the compounding itself ^[1].

"Patients deserve to know what they're getting — compounded GLP-1 products have not been proven safe, effective, or of consistent quality like FDA-approved drugs," Michael Davis, acting director of the FDA's Center for Drug Evaluation and Research, wrote on X ^[1]. "We will continue holding companies accountable."

Compounded drugs are made when a licensed pharmacist or physician mixes, combines or changes ingredients to fit one patient's needs, and the FDA does not approve them ^[1]. Under FDA definitions, the practice is meant for limited situations — a dye-free version for someone with an allergy, for example ^[2].

Semaglutide is the molecule in Novo Nordisk's Ozempic and Wegovy; tirzepatide is the molecule in Eli Lilly's Mounjaro and Zepbound ^[1].

Pressure on the category has been building

The June letters follow a March 2026 round in which the FDA warned 30 telehealth firms about misleading marketing of compounded GLP-1 drugs ^[1]. In April 2026, the agency proposed removing Novo Nordisk's and Eli Lilly's weight-loss drugs from a key compounding list, a step that could curb large-scale output by outsourcing facilities ^[1]. Whether that proposal has been finalized has not been reported.

Eli Lilly's safety page tells patients that compounded products never carry FDA approval, and states that a federal court has confirmed compounders, telehealth companies, med-spas and others must stop producing copies of its approved tirzepatide medicines ^[2]. The company also warns that its testing of compounded tirzepatide combined with vitamin B12 found significant levels of an impurity created by a reaction between the two ingredients, and that the short- and long-term effects of that impurity in people are unknown because the combination has never been studied ^[2].

The same page notes that retatrutide, an investigational molecule Lilly is studying in Phase 3 trials, is not approved by the FDA or any other regulator, and that the FDA has said it may not be used in compounding ^[2]. Lilly says it has filed six new lawsuits against US sellers of black-market retatrutide and has referred hundreds of bad actors to regulators and law enforcement ^[2].

Why it matters for patients

The gap between an approved GLP-1 medicine and a compounded one comes down to review. FDA-approved products have been assessed for safety, effectiveness and quality before reaching the market; compounded versions have not ^[1][2]. Statements that a compounded drug matches an approved product, or that it came from an FDA-approved pharmacy, are the kind the agency challenged in these letters ^[1].

The agency's own caution, quoted on Lilly's page, is that compounded drugs carry higher risk than FDA-approved drugs and should be used only when a patient's medical needs cannot be met by an approved product ^[2].

Because warning letters are posted publicly, patients can check whether a particular company appears on the FDA's site ^[1]. Not all 25 recipients have been identified in what has been reported. A warning letter is an agency allegation rather than a court decision, and the report did not describe what response, if any, the letters require or whether any company has replied ^[1].

What happens next

FDA officials said the agency will keep holding companies accountable ^[1]. No deadlines for company replies and no dates for further enforcement have been reported. The April 2026 proposal on the compounding list also has no announced decision date ^[1]. Lilly's page points to its lawsuits and referrals but gives no dates or outcomes for those cases ^[2].