FDA crackdown puts focus on risks of compounded GLP-1 weight-loss drugs
The FDA has announced plans to crack down on active pharmaceutical ingredients used in compounded GLP-1 drugs and warned about the risks of these products. The agency has cited counterfeit products, non-FDA-approved ingredients and more than 1,000 adverse event reports tied to compounded semaglutide and tirzepatide.
The U.S. Food and Drug Administration recently announced plans to crack down on the active pharmaceutical ingredients used in glucagonlike peptide 1 (GLP-1) drugs produced at compounding pharmacies. In February 2026, the FDA released a report alerting patients and providers about the risks of compounded GLP-1 medications.
As of April 2026, the most popular GLP-1 medications approved by the Food and Drug Administration include semaglutide, sold under the brand names Wegovy, Ozempic and Rybelsus; tirzepatide, sold as Mounjaro or Zepbound; and orforglipron, sold as Foundayo. These brand-name medications have undergone rigorous clinical trials and extensive FDA evaluation, including review of clinical data, manufacturing processes and facility inspections, to ensure safety, quality and effectiveness.
Many of the GLP-1 drugs advertised on the internet are not the FDA-approved medications but rather “compounded” GLP-1 products made in compounding pharmacies. They contain the same active ingredient – semaglutide, tirzepatide or orforglipron – but add minor but clinically important modifications such as using a different salt form, adding different inactive ingredients and varying drug concentrations or dosages. In addition, they may be often produced and stored under inconsistent quality standards.
Compounding pharmacies are intended to create personalized versions of FDA-approved medications to meet unique patient needs that cannot be met through the mass-produced brand-name medications. However, there is no evidence to suggest that the modifications being made to GLP-1 medications sold by compounding pharmacies meet those criteria.
The FDA report notes the presence of counterfeit Ozempic, the use of non-FDA-approved ingredients such as retatrutide or cagrilintide, and products bypassing regulations by being labeled as “not for human consumption.” As of July 2024 – the most recently issued report – the FDA had received over 1,000 reports of adverse events related to compounded semaglutide and compounded tirzepatide.
These include gastrointestinal effects like nausea, vomiting and abdominal pain, as well as fainting, headache, migraine, dehydration, acute pancreatitis and gallstones. These effects occur because drug concentrations in compounded medications can vary significantly, leading to serious dosing errors.
Websites selling compounded versions of GLP-1 drugs are not allowed to use the FDA-approved brand names of products like Ozempic, Wegovy and Zepbound. If a product description includes spelling errors or terms such as “compounded,” “generic version” or “same active ingredient as [brand name],” it often indicates that the product is a compounded formulation.