Hims & Hers drops $49 compounded semaglutide pill after FDA threat and Novo Nordisk lawsuit

Hims & Hers began offering a compounded semaglutide pill at $49 a month on February 5, 2026, undercutting the Wegovy pill made by Novo Nordisk ^[1][5]. Two days later, the company said it would stop offering the treatment, after the FDA announced it would restrict the ingredients used in compounded GLP-1 products and a top federal health lawyer referred the product to the Justice Department ^[4][5]. Novo Nordisk sued Hims & Hers for patent infringement on February 9 ^[2].

The Hims & Hers pill started at $49 for the first month with a five-month plan, and the company did not disclose the full pricing range ^[1]. Wegovy's once-daily pill, which launched January 5, is priced at $149 per month for the first two fills, rising to $299 per month for later refills and higher doses, according to distributor GoodRx ^[1]. Reuters described the Hims & Hers price as an introductory $49 per month, about $100 less than the brand-name product ^[5]. Healthline reported the Hims & Hers pill at $49 per month without the plan detail ^[3].

Investors reacted immediately. Novo Nordisk shares fell more than 8% on February 5 to close at $43.34, and Hims & Hers shares rose about 20% in premarket trading before closing down 3.8% at $23.48, then slipping another 1% after hours ^[1]. Novo Nordisk and Eli Lilly shares both sold off after the launch ^[5]. By February 13, Hims & Hers stock was down 29.2% from where it stood before the lawsuit and the Justice Department referral ^[6].

On February 6, the FDA said it would move to restrict GLP-1 active pharmaceutical ingredients used in compounded products that are not FDA-approved, and to act against misleading direct-to-consumer advertising. The agency named Hims & Hers and warned that companies making, distributing or marketing unapproved compounded GLP-1 products could face "legal action without further notice, including, without limitation, seizure and injunction" ^[2]. The same day, HHS General Counsel Mike Stuart said he would refer the compounded drug to the Justice Department for potential violations of the Federal Food, Drug, and Cosmetic Act and possible offenses under Title 18 of the U.S. Code ^[3][5]. FDA Commissioner Dr. 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].

Hims & Hers announced it would pull the pill 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]. Novo Nordisk had said earlier that week that it planned legal and regulatory action, calling the launch "another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products" ^[1]. In its February 9 patent suit, Novo Nordisk alleged Hims & Hers was mass-compounding injectable versions of Wegovy using "inauthentic API" and promoting its products as comparable to Wegovy, "putting patient health and well-being at risk" ^[2]. Hims & Hers has argued that its use of semaglutide is personalized to individual patients and therefore allowed under pharmacy law ^[1], and its chief executive, Andrew Dudum, has accused Novo Nordisk of trying to control how Hims clinicians make decisions ^[5].

Why it matters for patients

Compounded semaglutide is not FDA-approved, and its ingredients, concentration and additives can vary because pharmacies mix it themselves rather than using the branded formulation ^[1]. The Hims & Hers pill had not gone through clinical trials to prove it works ^[5]. The FDA has said that "compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug" ^[1]. In 2024, the agency warned it had received reports of hospitalizations and adverse effects from compounded semaglutide injections tied to dosing errors ^[1].

Compounding rules also changed. During the semaglutide shortage in 2024 and early 2025, pharmacies could legally produce bulk compounded versions; those allowances have since lifted, so pharmacies may compound only case by case for unique clinical needs ^[1]. The FDA has said that state-licensed 503A pharmacies are still subject to federal law for the products they make ^[2].

Price remains part of the picture. Alongside the Wegovy pill pricing ^[1], the federal TrumpRx site, launched February 5, lists semaglutide tablets at $149 to $299 a month, semaglutide injections at $199 to $349, and tirzepatide injections at $299 to $449, compared with list prices of $1,349 and $1,087 respectively ^[2].

What happens next

It is not yet clear how quickly the Justice Department will act on the referral ^[5]. Novo Nordisk's patent lawsuit, filed February 9, is pending ^[2]. The FDA published a January 16 warning letter to 503A pharmacy Boothwyn Pharmacy on February 10, citing insanitary conditions and problems with the strength, quality or purity of compounded products ^[2]. Eli Lilly's oral GLP-1 pill is expected to launch in April ^[5]. Whether Hims & Hers continues selling compounded semaglutide injections on its website has not been disclosed; the company did not answer a Reuters question about it ^[5].