FDA Cracks Down on Compounded Weight-Loss Drugs Amid Safety Concerns

Popular weight-loss drugs, including Ozempic, Wegovy, Trulicity, and Mounjaro, produced by independent pharmacy labs, have sickened thousands of individuals. As of 2024, over 8,000 Marylanders reported adverse effects linked to these compounded medications . The Food and Drug Administration (FDA) is now increasing its scrutiny of these compounded versions, particularly those from brands like Hims and Hers.

The Risks of Compounded GLP-1 Drugs

Compounded drugs are not equivalent to FDA-approved medications. Dr. Rozalina McCoy, an adult endocrinologist and researcher at the University of Maryland School of Medicine, emphasized this distinction, stating that compounded products are not generic versions but rather attempts to recreate the medication in independent labs . This process introduces significant safety concerns.

Approximately 12% of Americans are currently using some form of glucagon-based drugs . While a national shortage that spurred the demand for compounded alternatives may have eased in early 2025, the high cost of FDA-approved drugs continues to drive some patients to seek cheaper options. The Maryland Poison Center reported a 1500% increase in calls related to compounded GLP-1 medications between 2020 and 2025 .

A Regulatory Gray Area

Compounding pharmacies traditionally fill a crucial need by creating customized medications for patients with specific requirements, such as those who cannot swallow pills and require liquid formulations. The FDA temporarily allowed compounding of popular weight loss and diabetes drugs due to national shortages. But, the emergence of unauthorized compounded products from med spas, clinics, and online retailers has raised serious concerns.

These unauthorized products often lack FDA regulatory oversight and are sometimes available without a prescription. The Maryland Poison Center warns of potential therapeutic errors, lack of quality control, and the risk of contamination or the inclusion of foreign substances .

Reported Side Effects

Common side effects associated with compounded weight-loss drugs include nausea, severe abdominal pain, vomiting, diarrhea, and food intolerance. Symptoms can persist for days due to the drugs’ long half-life. More serious adverse effects can include dehydration, electrolyte imbalances, vitamin deficiencies, and hypoglycemia .

Dr. McCoy explained that the complex manufacturing processes of these protein-based medications, coupled with challenges in absorption, leave compounding pharmacies with considerable uncertainty. She likened the process to “trying to bake a cake from a picture,” highlighting the lack of control over the final product.

Cost and Access Concerns

Compounded GLP-1 drugs can range in price from $150 to $1,000 per month, and many insurance providers do not cover them for weight loss . Addressing the need for affordable and accessible medications is crucial, but safety must remain the top priority.

FDA Action and Ongoing Concerns

The FDA issued a warning letter to Eli Lilly and Company on September 9, 2025, regarding promotional communications for ZEPBOUND® (tirzepatide) and MOUNJARO® (tirzepatide) . The FDA determined that a video featuring paid consultants and a company vice president contained false or misleading information about the drugs.

Maryland Attorney General Anthony G. Brown has joined a bipartisan coalition of 37 states and territories urging the FDA to take swift action against online retailers selling counterfeit and unregulated GLP-1 drugs . The coalition emphasizes the risks to consumer safety and the need for stricter enforcement.

Ozempic was initially approved by the FDA on December 5, 2017, and later approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes on January 16, 2020 .