A pharmacist holds up a box of Wegovy pills for a news photographer somewhere in a Provo, Utah pharmacy. The product catches the light in a way that makes it appear almost ceremonial. It’s a fair representation of what these medications have turned into: the most talked-about pharmaceuticals in a generation, with enough cultural significance that their brand names have become commonplace, much like Kleenex and Band-Aid once did. However, a different, much messier, and much less photographed version of this story is unfolding in living rooms, telehealth portals, and compounding pharmacies across the nation behind the brand-name boxes, the meticulously managed supply chains, the Novo Nordisk lawsuits, and the FDA warning letters.
GLP-1 medications used by millions of Americans have never undergone an FDA safety, efficacy, or quality review. Some of these products come in packaging that lists pharmacies that don’t really exist, warm, and without proper refrigeration. There is no proof that the salt forms of semaglutide, such as semaglutide sodium or semaglutide acetate, behave similarly in the human body and are chemically different from the active ingredient in the approved medications.
| Category | Detail |
|---|---|
| Drugs Affected | Semaglutide (Ozempic, Wegovy), Tirzepatide (Mounjaro, Zepbound) |
| Brand Manufacturers | Novo Nordisk (semaglutide), Eli Lilly (tirzepatide) |
| Compounded Drug Definition | Pharmacy-mixed versions of medications — not FDA-approved for safety, effectiveness, or quality |
| Legal Action | Novo Nordisk sued Hims & Hers Health for selling compounded, unapproved semaglutide versions |
| FDA Adverse Events (by July 31, 2025) | 605 reports for compounded semaglutide; 545 for compounded tirzepatide |
| Key FDA Concern | Improper storage, dosing errors, fraudulent labeling, salt-form substitutions |
| Illegal Products Found | Counterfeit Ozempic; products labeled “for research purposes” sold directly to consumers |
| Underreporting Problem | State-licensed pharmacies not required to submit adverse events to FDA — true numbers likely much higher |
| European Warning | EMA warned in September 2025 of illegal GLP-1 medicines posing serious health risks across the EU |
| Banned Substances in Compounding | Retatrutide and cagrilintide cannot legally be used in compounding under federal law |
| Reference | U.S. Food and Drug Administration — GLP-1 Safety Information |
Some are sold online with labels such as “for research purposes only” or “not for human consumption,” along with dosage guidelines. Nevertheless, people continue to inject them. Unfavorable incidents are mounting. Furthermore, because the majority of compounding pharmacies are not legally obligated to report adverse events at all, the FDA has admitted in its own public communications that what is being reported most likely represents a fraction of what is actually happening.
The figures that are available are worth considering. As of July 31, 2025, the FDA had received 545 reports related to compounded tirzepatide and 605 reports of adverse events related to compounded semaglutide. They are the ones that entered the system. The agency has made it clear that adverse events from these medications’ compounded forms are probably greatly underreported. The discrepancy between reported and actual harm may be significant because compounded GLP-1 products have been prescribed to a huge number of patients, primarily due to insurance barriers that prevented branded versions from being available or affordable. How much is still unknown. One of the most worrisome aspects of this circumstance is that uncertainty.
The market came to this conclusion through a series of choices that, while each one seemed reasonable on its own, together resulted in something that no one fully intended. For a while, patients who required medication were unable to obtain branded tirzepatide and semaglutide because demand exceeded supply. In those circumstances, FDA regulations permitted compounding pharmacies to make substitutes for the medications.
That is a legitimate mechanism that serves a legitimate purpose. Compounding is necessary because some patients have allergies to common excipients, require a dose that is not commercially available, or simply cannot tolerate an FDA-approved formulation. According to Mike Doustdar, CEO of Novo Nordisk, the issue is that what began as a focused provision for specific medical needs evolved into something completely different. mass compounding. manufacturing unapproved drug copies on a large scale and distributing them via telehealth platforms to anyone who could fill out an online form and pay cash.
After Hims & Hers started selling a compounded oral version of semaglutide that mimicked the structure of Novo’s recently introduced daily pill, Novo Nordisk filed a lawsuit against Hims & Hers Health, making it one of the most prominent players in this market. In response, Hims & Hers presented the lawsuit as an attempt by a major pharmaceutical company to deny patients access to reasonably priced healthcare. That argument has merit.
Many Americans without insurance cannot afford the price tags of branded Ozempic and Wegovy, and insurance coverage for these medications is still inconsistent and disputed. The telehealth firms entered an actual access gap. However, filling an access gap with an unreviewed product that is kept at unpredictable temperatures and is made from raw materials that are sourced from vendors that the FDA has identified as having quality issues is not the same as resolving an access issue. It’s making a new one.
Clinicians who have personally experienced the fallout are especially concerned about the dosage issues. Patients must measure and self-administer their own doses of compounded injectable semaglutide, which usually comes in multi-dose vials. This procedure may seem doable until it becomes difficult. Numerous reports of hospitalizations caused by dosing errors have been sent to the FDA. These reports include patients drawing incorrect volumes, medical professionals calculating concentrations incorrectly, and individuals titrating more quickly than any approved schedule would allow. The symptoms that follow—severe nausea, vomiting, diarrhea, and abdominal pain—overlap with the side effects of approved GLP-1 medications, so patients may not immediately associate the issue with a dosage error. They simply don’t know why they feel so sick.
It’s difficult to ignore the structural familiarity of the entire situation. The opioid crisis also included a genuinely helpful class of drugs, a supply chain that expanded to meet that demand while paying less attention to the suitability of each individual patient, and a regulatory body that moved more slowly than the market. The GLP-1 situation differs significantly in that these medications are not addictive in the same sense and they address a significant and genuine medical need.
However, the pattern of a potent drug, a sizable and unregulated black market, and the accumulation of underreported side effects while the legal disputes take place in the background is one that medicine has seen before. This time, the results might be better. It’s also possible that the complete reckoning is still quietly taking shape in a database of unfavorable occurrences to which the majority of compounders are not required by law to contribute.
