Hims & Hers shares fall on the FDA's unapproved GLP-1 warning

Shares of Hims & Hers Health fell after the Food and Drug Administration issued a warning to telehealth companies and compounding pharmacies about unapproved weight-loss drugs, including versions of semaglutide, tirzepatide and retatrutide ^[1]. One source put the decline at 3.2 percent ^[1], while another reported the stock fell 4 percent to close at $28.44 ^[2]; the sources do not agree on the exact size of the move.

The FDA reiterated that retatrutide and cagrilintide cannot legally be used in compounding, and said it had already warned companies marketing unapproved retatrutide directly to consumers ^[1]. The agency said compounded GLP-1 drugs are not FDA-approved and have not been reviewed for safety, effectiveness or quality before being sold to patients ^[1].

As of May 31, the FDA had received 990 adverse-event reports linked to compounded semaglutide and more than 730 tied to compounded tirzepatide ^[1][2]. The agency cautioned that this total may undercount actual harm, since most state-licensed pharmacies are not required to report adverse events ^[2]. Regulators also flagged dosing errors that sometimes required hospitalization, contamination risks from multidose vials used beyond 28 days, inadequate refrigeration during shipping, fraudulent labels, and semaglutide salt forms with no established lawful basis for compounding ^[1][2]. The FDA also set up an import "green list" meant to keep GLP-1 ingredients with quality concerns out of the U.S. supply chain while still allowing shipments from compliant manufacturers ^[2].

Why it matters for patients

This warning lands even though Hims & Hers, the largest telehealth GLP-1 seller, has already moved away from mass-marketing compounded semaglutide. Under a March agreement with Novo Nordisk, Hims now mainly offers FDA-approved Ozempic and Wegovy, and it stopped advertising compounded GLP-1s, reserving them for patients whose clinicians document a specific need that approved drugs cannot meet ^[2]. That shift followed a brief February launch of a compounded oral semaglutide pill priced from $49 a month, which Hims pulled after about two days, and a patent lawsuit from Novo that was later dismissed once the distribution deal was reached ^[2].

For patients, the episode is a reminder that compounded GLP-1 products — whether semaglutide, tirzepatide or newer molecules like retatrutide — sit outside the FDA's standard approval process. The agency's own numbers on dosing errors, contamination and mislabeling suggest quality control has been inconsistent across the compounding market, even as some patients turned to compounded versions for cost or supply reasons ^[1][2]. The stock reaction also shows that telehealth companies' financial health remains closely tied to compounding rules, which can affect pricing, product availability and how aggressively these platforms market weight-loss drugs going forward.

The business fallout is already visible in Hims' own numbers. The company's second-quarter gross margin fell to about 64 percent from 76 percent a year earlier, because FDA-approved GLP-1 drugs cost more than compounded copies ^[2]. Hims reported $753 million in quarterly revenue and an $86 million net loss, which included restructuring costs and legal accruals ^[2]. Even so, the company raised its 2026 revenue forecast to between $3.1 billion and $3.3 billion, and said nearly all of its new weight-loss customers have signed up for branded products since March ^[2]. Hims stock has fallen 33 percent over the past year ^[2].

What happens next

The sources do not specify a firm timeline for further FDA action beyond the September 1 warning and the existing May 31 adverse-event data cutoff ^[1][2]. It is not yet known whether the agency will issue additional enforcement actions against specific compounding pharmacies or telehealth firms marketing retatrutide or other unapproved GLP-1 products, or how the import "green list" will be applied to specific manufacturers.