FDA tally of adverse event reports for compounded GLP-1s passes 1,700
The FDA's count of reports naming compounded semaglutide and tirzepatide has topped 1,700, and the agency says its own figure is incomplete.
As of May 31, 2026, the FDA had logged 990 reports naming compounded semaglutide and more than 730 naming compounded tirzepatide, pushing the combined figure past 1,700 [1].
Reporting a problem is not the same as proving a cause. The FDA notes that a report means someone named the product, and it has not said how many of the 1,700-plus cases involved hospital stays, serious harm or death [1]. The tally itself is incomplete: pharmacies licensed under section 503A of the federal drug law are not obligated to file adverse event reports, so the agency expects the true number is higher [1].
Dosing confusion shows up in the data
A separate tracking system, America's Poison Centers, handled 22,966 GLP-1 exposure cases between 2019 and 2025, with annual call volume climbing almost 1,500% across those seven years [1]. Accidental therapeutic errors involving FDA-approved products accounted for most of them [1]. Among compounded products, the pattern that stands out is a dose ten times the intended amount, which the reporting ties to mix-ups over the units marked on a syringe [1].
Labeling has been another issue. The FDA has said some compounded semaglutide and tirzepatide shipments carried labels naming pharmacies that either do not exist or had no role in making the drug [1].
How the market got this large
Compounding grew out of shortages. Wegovy went on the FDA shortage list in March 2022, Ozempic that August and tirzepatide that December, which created a narrow opening for pharmacies to sell copies of patented medicines [1]. Compounded semaglutide is a copy of the molecule in Novo Nordisk's Ozempic and Wegovy [1]. Novo estimated in January that roughly 1.5 million Americans were still taking a compounded GLP-1 [1]. A JAMA Health Forum study published this summer counted 75 clinics and medical spas selling compounded GLP-1s in Oklahoma and West Virginia alone [1].
Money followed. An internal dashboard obtained by the Houston Chronicle showed Houston-based Empower Pharmacy booked $311 million in the first 10 months of 2024, with GLP-1 formulations making up 66% of that sum; the company told the Houston Business Journal its full-year revenue reached $377 million, against $119 million in 2022 [1]. Bankers quoted by Bloomberg put compounded weight-loss drugs at as much as $1 billion a year across pharmacies [1].
Regulators have narrowed the opening since. The tirzepatide shortage ended in December 2024 and the semaglutide shortage in February 2025, and the final enforcement discretion window shut on May 22, 2025 [1]. The FDA issued more than 55 warning letters to online sellers in one day in September 2025, 30 more in February 2026 and another 25 in June 2026 [1]. In February 2026 the agency sent a warning letter to MEDVi alleging that the company's branding hid where its compounded semaglutide and tirzepatide came from and implied the products were equivalent to approved drugs; MEDVi said it never received the letter and that it was addressed to an affiliate [1].
Why it matters for patients
Compounded semaglutide and tirzepatide are not FDA-approved drugs. Approval applies to a specific finished product from a specific manufacturer, and compounded versions are mixed by individual pharmacies, so what is in the vial and what the label says can differ from one seller to the next [1].
The report counts do not tell anyone whether a particular compounded product is risky. They show what has been filed, and the FDA's own figure is a floor rather than a ceiling [1]. Two concrete details are checkable: the syringe-unit confusion behind the reported 10-fold errors, and labels on some products naming pharmacies that did not make them [1].
Consumers have also described billing problems in this market. Customers of FitRx and Zealthy reported charges that were not clearly disclosed, subscriptions that renewed automatically and cancellations that were hard to complete, including an $866 charge one WIRED contributor disputed after registering to see the price of compounded tirzepatide [1].
What happens next
The SAFE Drugs Act of 2025 would cap 503A compounding of a drug that is "essentially a copy" of a marketed product at 20 times per month unless a prescriber documents a patient-specific difference. It was still before the House Energy and Commerce Committee as of August 2026, and the Alliance for Pharmacy Compounding and the National Community Pharmacists Association oppose the 20-unit limit and added reporting duties [1].
In the courts, Novo Nordisk sued Hims & Hers in February 2026 for patent infringement and says it has brought 132 suits in 40 states, winning 44 permanent injunctions [1]. Eli Lilly sued Strive Pharmacy and Empower in April 2025 and four telehealth companies weeks later [1]. The Outsourcing Facilities Association challenged both shortage determinations in late 2024 [1]. A civil RICO case alleging OpenLoop Health and Triad Rx ran infrastructure behind telehealth storefronts selling oral tirzepatide is pending; MEDVi is named as one such storefront but is not a defendant [1]. No date has been disclosed for the FDA's next update to its adverse event tally [1].
Sources
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