Hims & Hers launches a $49 compounded semaglutide pill

Telehealth company Hims & Hers announced a compounded semaglutide pill on February 5, 2026, priced starting at $49 a month — roughly $100 less than the brand-name Wegovy pill ^[3][5]. Within two days the company stopped selling it, after the U.S. Food and Drug Administration said it would act against unapproved compounded GLP-1 products and the Department of Health and Human Services referred the company to the Justice Department ^[4][5].

The launch undercut Novo Nordisk's oral Wegovy, which debuted January 5 at a self-pay price of $149 a month ^[3]. According to GoodRx, the Wegovy pill runs $149 per month for the first two fills, then $299 a month for later refills and higher doses ^[1]. Hims said its price started at $49 for the first month on a five-month plan, and did not disclose the full pricing range ^[1].

Markets moved fast. Novo Nordisk shares fell more than 8% on February 5 to close at $43.34, and Eli Lilly shares also sold off; Lilly's own oral GLP-1 is expected to launch in April ^[1][5]. Hims shares jumped about 20% in premarket trading, then closed down 3.8% at $23.48 ^[1]. By mid-February, Hims stock was down 29.2% following the lawsuit and DOJ referral ^[6].

The federal response

On February 6, the FDA announced it would take steps to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded products and to combat misleading direct-to-consumer marketing ^[2][5]. The agency warned that companies "engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products" that fail to fix violations "may result in legal action without further notice, including, without limitation, seizure and injunction" ^[2]. The FDA named Hims & Hers specifically ^[2]. FDA Commissioner Marty Makary said the agency would "use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns" ^[5].

HHS General Counsel Mike Stuart said he would refer the product to the Justice Department over potential violations of the Federal Food, Drug, and Cosmetic Act and possible offenses under Title 18 of the U.S. Code ^[3][5].

Hims relented on February 7. "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 ^[5]. On February 9, Novo Nordisk sued Hims & Hers for infringing U.S. Patent No. 8,129,343 with its compounded semaglutide products, alleging the company mass-compounds injectable copies made with "inauthentic API" ^[2].

Why it matters for patients

Compounded semaglutide is mixed by a pharmacy rather than made by the brand manufacturer. It is not FDA-approved, and Hims' pill did not go through clinical trials showing how well it works ^[1][5]. Ingredients, concentration and additives can vary ^[1]. Healthline reported that experts say it is unclear whether the Hims pills perform as well as Wegovy ^[3]. The FDA warned in 2024 that it had received reports of hospitalizations and side effects tied to dosing errors with compounded semaglutide injections, and said in early February 2026 that "compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug" ^[1].

The legal footing also shifted. During the 2024–early 2025 semaglutide shortage, pharmacies could legally produce bulk compounded versions; those allowances have lifted, so pharmacies may generally compound only case-by-case for a specific patient's clinical need ^[1]. Hims argues its products are personalized and therefore allowed ^[1]. Novo calls that a "false guise of 'personalization'" ^[1].

On price, brand options got cheaper the same week. TrumpRx launched February 5 listing semaglutide tablets at $149 to $299 a month versus $1,349, semaglutide injections at $199 to $349, and tirzepatide injections at $299 to $449 versus $1,087 ^[2].

What happens next

The Novo patent suit filed February 9 is unresolved ^[2]. Hims did not answer Reuters' question about whether it will keep selling compounded semaglutide injections ^[5], and it is not yet known whether the DOJ will bring a case. The FDA has said further action could include recalls, seizures and injunctions ^[2].