The FDA has outlined numerous concerns about the sale and use of unapproved GLP-1 drugs for weight loss. 

The statement was posted the same week as the online telehealth company Hims & Hers announced a lower-priced compounded version of the semaglutide pill, prompting Wegovy manufacturer Novo Nordisk to threaten legal action, followed by Hims & Hers withdrawing the pill.  However, the new statement highlights concerns that extend beyond just those pertaining to that one product.

“FDA is aware that some patients and healthcare professionals may look to unapproved versions of GLP-1 [GLP-1 receptor agonists] drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness, and quality before they are marketed,” the agency said.

Compounded drugs are appropriate only in specific situations, such as when a patient’s medical need can’t be met by an FDA-approved drug, or in shortage situations. But, because they are not FDA-approved, “the agency does not review compounded drugs for safety, effectiveness, or quality before they are marketed.”

The FDA recommends that when compounded drugs are prescribed, patients be instructed to fill the prescription at a state-licensed pharmacy, or visit the FDA’s BeSafeRx site for resources to safely buy prescription drugs online.

The FDA’s areas of concern about unapproved GLP-1 drugs include:

Improper storage during shipping of injected GLP-1s. The FDA has received complaints that compounded injectable GLP-1 drugs have arrived warm or with inadequate ice packs to keep them at recommended storage temperatures.

Actions at the border. In September 2025, the FDA established a “Green List” of imported GLP-1 drug ingredients deemed safe and allowed into the country, while keeping out those from unverified foreign sources. Now, a new green list “import alert” signals that the agency believes certain drugs compounded from GLP-1 active pharmaceutical ingredients may be adulterated.

Fraudulent compounded GLP-1s. The FDA is aware of fraudulent compounded semaglutide and tirzepatide labeled with false information. In some cases, the pharmacy listed on the label doesn’t exist, or the label names a licensed pharmacy that did not compound the product. In one case, redness, site swelling, and pain were reported in conjunction with one such fraudulent GLP-1 product. 

Dosing concerns with compounded injectable GLP-1s. The FDA has received several reports of adverse events, some severe, related to dosing errors made by both patients and clinicians. “Healthcare providers should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients,” the FDA said.

Compounding of not-yet-licensed GLP-1 drugs. Neither retatrutide nor cagrilintide (currently investigated in combination with semaglutide as CagriSema) are FDA-approved and therefore cannot be legally compounded, yet the FDA has had to issue warning letters to companies distributing their active ingredients.

Salt forms. Some compounded semaglutide products may contain salt forms such as semaglutide sodium or semaglutide acetate. “The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding,” the FDA said.

Counterfeit Ozempic. The FDA is aware that some compounded versions contain the wrong ingredients, the wrong amount, no active ingredients, or other harmful ingredients, sold illegally both in person and online. The agency investigates reports of suspected counterfeit drugs and “remains vigilant in protecting the US drug supply from these threats.”

Anyone experiencing an adverse event or quality problem with any medications is encouraged to report it to the FDA’s Medwatch Adverse Events Reporting Program.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.