Hims & Hers pulls compounded semaglutide pill after federal warning

Federal regulators said they would move against unapproved compounded GLP-1 products, and telehealth company Hims & Hers announced it would stop offering access to a compounded semaglutide pill on its platform. The decision follows agency warnings about the quality, safety and legality of mass-compounded versions of drugs like Wegovy and an interagency referral to the Justice Department.

“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment,” the company said in a statement. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”

The product had been marketed as a low-price oral semaglutide option, with a $49 introductory month and $99 per month thereafter. By comparison, the brand Wegovy sells for roughly $149 per month. Hims positioned the offering as a cheaper alternative for patients seeking GLP-1 medicines outside traditional specialty channels, part of a broader push by telehealth firms into the multibillion-dollar obesity drug market.

Regulators said the proliferation of compounded GLP-1 products raised public health concerns. “[The FDA will] use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns,” said FDA Commissioner Marty Makary. The Department of Health and Human Services said it would refer the matter to the Department of Justice, signaling potential legal scrutiny beyond administrative enforcement.

Industry rivals moved quickly to denounce the offering and warn of legal steps. Ambre James-Brown, a Novo Nordisk spokeswoman, said, “Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework.” A spokesperson for Eli Lilly added: “No one should be mass-compounding or selling knockoff GLP-1 products regardless of how they’re administered.”

The episode exposed tensions between consumer demand for lower-cost options and a regulatory framework that limits compounding to narrow circumstances. Compounding pharmacies are permitted to create patient-specific formulations, particularly during validated shortages or when a prescriber requires a custom dose. Regulators had declared in 2024 that GLP-1 drugs were no longer in shortage, a development that officials say should curtail mass compounding of those medicines.

The enforcement announcement and Hims’ subsequent move unsettled investors and users. The company’s shares fell sharply after the regulatory statement, and observers noted that Hims’ website still promoted the semaglutide pill hours after the company said it would stop offering access, indicating a lag between the public pronouncement and product listings. Hims has not clarified whether it will suspend sales of compounded injectable GLP-1 products it also offers.

The dispute follows a rocky commercial history between telehealth firms and established drugmakers. Hims previously entered and later exited a 2025 partnership with Novo Nordisk amid accusations over marketing and competition. As federal agencies signal tougher scrutiny, telehealth companies, manufacturers and pharmacies face a narrowing margin for operating low-cost copycat products without running afoul of drug safety and intellectual property rules.

Regulators did not spell out an immediate timetable for enforcement actions or legal referrals. The outcome will likely hinge on whether authorities pursue administrative penalties, litigation, or both, and on how companies adjust their offerings in response to the increased oversight.