FDA warns of severe risks from misbranded GLP-1 weight-loss drugs
The FDA warned patients and providers about severe health risks from unapproved and compounded GLP-1 weight-loss drugs, including illegally marketed semaglutide and tirzepatide. Hims & Hers stock closed 3.85% lower Tuesday.
The U.S. Food and Drug Administration on Tuesday warned patients and healthcare providers about severe health risks tied to unapproved and compounded glucagon-like peptide-1, or GLP-1, weight-loss medicines. The agency said consumers are often exposed to illegally marketed semaglutide and tirzepatide products through online sellers, raising the risk of unsafe chemical formulations, improper dosing and product contamination. The warning followed a 3.85% decline in Hims & Hers Health Inc.
stock on Tuesday. As of May 31, 2026, the FDA said it had received 990 adverse event reports involving compounded semaglutide and over 730 reports involving compounded tirzepatide. Reported effects included hospitalizations, severe gastrointestinal symptoms such as nausea and vomiting, and injection site reactions from fraudulent formulations. Tirzepatide is the active ingredient in Eli Lilly and Co.'s Zepbound and Mounjaro, while semaglutide is the primary active ingredient in Novo Nordisk A/S's Ozempic and Wegovy.
Consumers face contamination risks when multi-dose vials are used beyond 28 days or shipments arrive unrefrigerated. Regulators have also warned against unapproved salt forms such as semaglutide sodium and semaglutide acetate.
The agency said federal law bars Eli Lilly’s retatrutide and Novo Nordisk’s cagrilintide from drug compounding, and that it has sent warning letters to active pharmaceutical ingredient distributors, outsourcing facilities and telehealth vendors marketing unauthorized drugs, including products labeled “for research purposes” or “not for human consumption.” To keep poor-quality foreign ingredients out of the domestic supply chain, the FDA has put import alert 66-80 in place for non-compliant manufacturers while allowing compliant imports. Hims & Hers Health shares were down 0.56% at $28.28 in premarket trading on Wednesday, according to Pro data.
Read also: Top Economist Says Trump Has Awakened the 'Bond Vigilantes' With Tariffs and Iran War as 10-Year Treasury Yield Surges to 19-Month High.