The U.S. Food and Drug Administration (FDA) on Tuesday warned patients and healthcare providers about severe health risks linked to unapproved and compounded glucagon-like peptide-1 (GLP-1) weight-loss medications.
Consumers frequently encounter illegally marketed semaglutide and tirzepatide products through online sellers, exposing themselves to unsafe chemical formulations, improper dosing, and product contamination.
Following the update, Hims & Hers Health Inc. (NYSE:HIMS) stock closed 3.85% lower on Tuesday.
Rising Adverse Events And Dosing Hazards
As of May 31, 2026, the agency received 990 adverse event reports regarding compounded Semaglutide and over 730 reports involving compounded tirzepatide.
Tirzepatide is the active ingredient in Eli Lilly and Co.’s (NYSE:LLY) Zepbound and Mounjaro, and Semaglutide is the primary active ingredient in Novo Nordisk A/S (NYSE:NVO) Ozempic and Wegovy.
Patients reported hospitalizations, severe gastrointestinal symptoms like nausea and vomiting, and injection site reactions from fraudulent formulations.
Additionally, compounders illegally use unapproved salt forms, such as semaglutide sodium and semaglutide acetate.
Consumers also face contamination risks when using multi-dose vials beyond 28 days or receiving unrefrigerated shipments.
Federal Crackdown On Illegal Distribution
Federal law strictly bans Eli Lilly’s retatrutide and Novo Nordisk’s cagrilintide in drug compounding.
Regulators issued warning letters to active pharmaceutical ingredient distributors, outsourcing facilities, and telehealth vendors marketing unauthorized drugs, including products falsely labeled “for research purposes” or “not for human consumption.”
To stop poor-quality foreign ingredients from entering the domestic supply chain, the agency implemented import alert 66-80 targeting non-compliant manufacturers while permitting compliant imports.
HIMS Price Action: Hims & Hers Health shares were down 0.56% at $28.28 during premarket trading on Wednesday, according to Benzinga Pro data.
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