Hims & Hers stock slips as FDA restates limits on compounded GLP-1 drugs

Hims & Hers Health (NYSE: HIMS) shares closed lower on Tuesday, September 1, the same day the Food and Drug Administration warned telehealth companies and compounding pharmacies about unapproved weight-loss drugs, among them compounded semaglutide, tirzepatide and retatrutide ^[1].

Accounts of the session give different figures. One report described a 3.2% decline ^[1]. Another said the stock lost 4% and finished at $28.44 ^[2]. The two reports covered the same trading day, and neither explained the difference.

On retatrutide and cagrilintide, the agency was direct: neither can legally be used in compounding, and the FDA said it had already sent warnings to companies marketing unapproved retatrutide straight to consumers ^[1]. Neither is an approved drug. Approved semaglutide products include Ozempic, Wegovy and Rybelsus; approved tirzepatide products include Mounjaro and Zepbound.

What the FDA counted

Through May 31, the FDA had logged 990 adverse-event reports naming compounded semaglutide and more than 730 naming compounded tirzepatide ^[1]. One account rendered that as more than 1,700 events across the two ^[2]. The agency added that the real count may be higher, because most state-licensed pharmacies are not obligated to file such reports ^[2].

Officials also pointed to specific failure modes: dosing mistakes that in some cases put patients in the hospital, contamination risk from multi-dose vials kept past 28 days, shipping that lacked proper refrigeration, fraudulent labels, semaglutide salt forms with no recognized legal basis for compounding, and raw ingredients of doubtful foreign origin ^[1][2]. To screen incoming supplies, the FDA set up an import "green list" that admits material from compliant manufacturers while keeping GLP-1 ingredients with quality concerns out of the country ^[2].

The agency's position on the category is unchanged: compounded GLP-1s have not been approved by the FDA and were not reviewed for safety, effectiveness or quality before being sold ^[1]. In the FDA's framing, an unapproved GLP-1 belongs in a treatment plan only when an approved option cannot meet that patient's needs ^[2].

A business built partly on compounded copies

Hims & Hers now leans on brand-name product. Under a March agreement with Novo Nordisk, its main weight-loss offering is FDA-approved Ozempic injections plus Wegovy injections and tablets, and it has stopped advertising compounded GLP-1s, keeping them for patients whose clinicians document a medical need the approved drugs cannot cover ^[2].

That came after a February rollout of compounded oral semaglutide priced from $49 a month, which the company pulled in roughly two days, citing "constructive conversations with stakeholders across the industry" ^[2]. Novo Nordisk sued over patent infringement, describing the launch as a "tipping point," then dropped the suit once the distribution deal was signed ^[2].

Switching to branded supply has cost the company margin. Gross margin in the second quarter was about 64%, down from 76% a year earlier, since approved GLP-1s cost more than compounded versions ^[2]. Hims & Hers posted $753 million in revenue and an $86 million net loss, a figure that includes restructuring costs and legal accruals, and lifted its 2026 revenue outlook to between $3.1 billion and $3.3 billion ^[2]. Nearly every new weight-loss customer since March has come in through a branded product ^[2]. The shares are down 33% over the past year ^[2].

Separately, the company began its Australia rollout on Monday by rebranding Pilot, which it gained by buying the digital-health firm Eucalyptus, and extended care-team availability from 12 hours a day to around the clock ^[2].

Why it matters for patients

Whatever the price, a compounded GLP-1 is not the reviewed product. There is no FDA sign-off on its safety, effectiveness or quality before it reaches a customer ^[1]. The problems regulators listed — wrong doses, spoiled or mishandled vials, mislabeled packaging, ingredients from unclear sources — are ones that can change what a patient actually gets ^[1][2].

Cost has been the main draw of compounded versions, which is visible in the Hims & Hers numbers: margin dropped about 12 percentage points once the mix shifted toward approved Ozempic and Wegovy ^[2]. Patients weighing price against provenance now have the FDA's stated view to factor in.

Not reported: which other companies, beyond Hims & Hers, the FDA contacted, whether the agency intends anything beyond warning letters, or how the 990 and 730 figures break down by outcome. No enforcement timetable has been disclosed.