Compounded & telehealth

Hims & Hers Semaglutide: What Happened

Hims & Hers built a weight loss business on compounded semaglutide, collided with Novo Nordisk and the FDA three separate times, ended up selling the branded drug it once undercut, and is now defending an FTC lawsuit over how it bills and how it handles health data.

Last verified September 14, 2026·20 sources cited

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If you signed up with Hims & Hers for weight loss in 2024, you probably got a compounded semaglutide vial for well under $200 a month. If you sign up today, you get branded Wegovy or Ozempic at a very different price.

The path between those two facts runs through a Super Bowl ad, an FDA warning letter, a partnership that lasted eight weeks, a $49 pill that lasted two days, a patent lawsuit, a referral to the Justice Department, a settlement, and — separately from all of it — a federal consumer protection lawsuit. Here is the sequence, with sources.

How did Hims & Hers get into weight loss?

Hims & Hers is a direct-to-consumer telehealth company that started with hair loss and erectile dysfunction and expanded outward. In May 2024 it added compounded semaglutide injections to its platform at prices far below branded Wegovy, and the stock jumped.

The legal basis was the shortage. Semaglutide had been on FDA’s drug shortage list since 2022, and while a drug is listed, compounding pharmacies and outsourcing facilities can legally make copies. Hims & Hers was not doing anything novel in kind; it was doing it at consumer-marketing scale, with a national brand behind it.

That scale is what eventually made it the test case.

The Super Bowl ad

On February 9, 2025 Hims & Hers ran a 60-second Super Bowl spot called “Sick of the System.” It called obesity America’s deadliest epidemic, attacked the $160 billion weight loss industry, described the health care system as broken, and offered the company’s own affordable, doctor-trusted compounded semaglutide as the answer.

What it did not do was carry the side effect, risk, and safety disclosures a branded prescription drug ad would have to include.

That is not an oversight; it is a structural gap. Prescription drug advertising rules apply to approved drugs. Compounded products are not approved drugs, so the ad rules that govern a Wegovy commercial did not govern this one.

Senators Dick Durbin and Roger Marshall, a Democrat and a Republican, wrote to FDA asking the agency to act, describing the ad’s failure to include “any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement” [1]. A pharmaceutical trade group and a number of physicians made similar complaints [2].

Nothing happened immediately. But the ad put the compounded GLP-1 advertising loophole in front of Congress, and the crackdown that followed a year later traces back to it.

The shortage ends

Twelve days after the Super Bowl, on February 21, 2025, FDA declared the semaglutide shortage resolved. Compounding pharmacies were given until April 22, 2025 to stop compounding it, and outsourcing facilities until May 22, 2025. Hims & Hers stock fell about 25 percent on the news.

The company’s position was that it could keep going under the personalized-dosing route: a compounded product tailored for an individual patient is not an “essentially a copy” product. That argument would be the center of everything that followed.

The Novo partnership, and its collapse eight weeks later

On April 29, 2025 Novo Nordisk announced it was making authentic Wegovy available at a discount through three telehealth platforms — Hims & Hers, LifeMD, and Ro — via its direct-to-patient NovoCare Pharmacy [3]. LifeMD and Ro sold it at $499 a month; Hims at $599 [4].

It looked like a truce. It lasted less than two months.

On June 23, 2025 Novo Nordisk terminated the Hims arrangement, saying the company had “failed to adhere to the law which prohibits mass sales of compounded drugs” and accusing it of deceptive marketing that put patient safety at risk [5][6]. HIMS shares fell roughly a third in a day, wiping out the gains from announcing the deal in the first place.

Securities class action lawsuits followed from investors who had bought in on the partnership news.

The FDA warning letter

On September 9, 2025 FDA sent a warning letter to Hims & Hers Health, Inc. dba Hers [7]. The agency said the compounded semaglutide products on the company’s website were misbranded because claims about them were false or misleading.

Two phrases were cited specifically:

“Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy”
“Clinically proven ingredients”

FDA’s objection was that these suggested the compounded products were equivalent to FDA-approved medications when compounded drugs receive no FDA premarket review for safety, effectiveness, or quality. The company was given 15 working days to respond, and the letter warned that failure to correct could lead to seizure and injunction.

That letter was part of a wave of more than 50 sent to GLP-1 compounders and online sellers in September 2025.

The Wegovy pill changes the math

On December 22, 2025 FDA approved the Wegovy pill, once-daily oral semaglutide 25 mg, the first oral GLP-1 approved for weight management. It launched in early January 2026 at $149 a month for cash-paying patients at starter doses.

Until then, compounders had argued that mass-compounding oral semaglutide filled a gap because no approved oral product for weight loss existed. Once one did, that argument was gone, and FDA expected compounders to stop.

The $49 pill, February 2026

On February 5, 2026 Hims & Hers announced a compounded semaglutide pill at $49 for the first month. It undercut the branded Wegovy pill at $149 by two thirds [8].

The reaction was immediate and came from the top of the federal government rather than from a routine regulatory channel.

The day after the announcement, the General Counsel of the Department of Health and Human Services said publicly that his office had referred Hims & Hers to the Department of Justice for investigation of potential violations of the Federal Food, Drug, and Cosmetic Act and related criminal provisions [9]. The same day, FDA announced it intended to restrict GLP-1 active ingredients used in non-FDA-approved compounded drugs mass-marketed as alternatives to approved products, warning that failure to fix violations could bring seizure and injunction without further notice. Hims & Hers was named in the FDA statement.

On February 7, 2026 — two days after launch — Hims & Hers said it would stop offering the compounded semaglutide pill [8].

Novo sues for patent infringement

On February 9, 2026 Novo Nordisk filed a patent infringement lawsuit against Hims & Hers, alleging infringement of U.S. Patent 8,129,343, which covers the semaglutide molecule [10]. Novo asked the court to permanently ban Hims from selling unapproved compounded drugs infringing its patents and sought damages.

Novo’s statement said Hims had “engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs,” and pointed to both the pill episode and continued mass compounding of injectable versions [10].

This was the first patent infringement case aimed at 503A semaglutide compounding rather than at a generic drug filer. Hims had argued its compounded pill was personalized and used a different release technology; Novo argued it was mass compounding that infringed the molecule patent regardless.

The settlement, March 2026

On March 9, 2026 the two companies announced a deal [11][12]:

Novo Nordisk dismissed the patent suit, without prejudice, reserving the right to refile.
Hims & Hers agreed to stop advertising compounded GLP-1 products on its platform or in its marketing.
Hims would offer oral and injectable branded Wegovy and Ozempic through its platform.
Hims said it would continue to offer compounded GLP-1s “if a provider determines that a compounded product is clinically necessary.”

HIMS shares surged on the announcement, in some reports by more than 35 percent.

The commercial logic on both sides was straightforward. Novo wanted distribution and wanted the copycat pressure to stop. Hims wanted the legal and regulatory overhang gone and needed a product to sell.

What it cost the business

The pivot was expensive, and the financial statements show exactly how.

In the first quarter of 2026, Hims & Hers reported revenue of about $608 million but swung to a $92.1 million net loss, against $49.5 million of net income in the same quarter a year earlier [13]. The reason was the mix shift: compounding your own semaglutide is a manufacturing business with high margins; buying branded Wegovy and reselling it is a distribution business.

In the second quarter of 2026, revenue rose 38 percent year over year to about $753 million, subscribers grew 19 percent to 2.89 million, and monthly revenue per subscriber rose 21 percent to $92. But gross margin fell from 76 percent to 64 percent, and the company posted an $86.3 million net loss [14], which included $47.5 million of legal contingencies, $28.8 million of acquisition and transaction costs, and $4.6 million of restructuring charges. Full-year revenue guidance was raised to $3.1 billion to $3.3 billion while the adjusted EBITDA ceiling was cut.

Management has said it expects to return to net profitability in 2027.

Alongside the pivot, the company moved hard into international growth, agreeing in February 2026 to acquire the Australian digital health company Eucalyptus for up to $1.15 billion, with about $240 million payable in cash at closing and the rest in deferred and earnout payments through early 2029 [15]. The deal closed in mid-2026 and added Australia, Japan, the United Kingdom, Germany, and Canada to the footprint.

What is still open

Three federal matters have not resolved publicly.

The FTC lawsuit. This is the largest of them and it is not about compounding at all. On July 29, 2026 the Federal Trade Commission, joined by the State of Utah and Los Angeles County acting on behalf of the people of California, sued Hims & Hers in the Northern District of California [18][19]. The complaint alleges violations of Section 5 of the FTC Act, the Restore Online Shoppers’ Confidence Act, and state consumer protection law, on three theories: that the company enrolled customers in automatically renewing “negative option” prescription subscriptions without adequately disclosing the terms, that it made cancellation unreasonably difficult, and that it shared sensitive health information with advertising platforms including Meta and Snap despite privacy representations to customers. The FTC’s investigation dated to October 2023. Hims & Hers denied wrongdoing, calling the suit unsupported after a nearly three-year investigation, and said it will defend itself [20]. HIMS shares fell roughly 10 to 12 percent on the news.

The financial trail is visible in the filings: a $15 million legal settlement accrual in the first quarter of 2026, then a further $47.5 million charge in the second quarter. The two are charges, not the balance: the Form 10-Q filed August 10, 2026 puts the accrued legal contingency for the FTC matter alone at approximately $60 million as of June 30, 2026, with total accrued legal contingencies of $62.5 million against $0 at the end of 2025. The same filing says settlement negotiations with the FTC were unsuccessful and discloses a follow-on consumer class action, Doe v. Hims & Hers Health, Inc., brought under the federal wiretap statute and two California privacy laws [21][22]. (updated 2026-09-14) A securities class action tied to the FTC disclosure followed, with a lead-plaintiff deadline of November 2, 2026. None of that establishes the allegations; it does establish that the company expects the matter to cost money.

The SEC investigation. Hims & Hers disclosed in its fiscal 2025 Form 10-K that it received a letter from the staff of the SEC’s Division of Enforcement notifying it of an investigation and asking it to preserve documents about its public statements and disclosures regarding compounded semaglutide and related business relationships. The company said it is cooperating and cannot predict the outcome or financial impact [16].

The DOJ referral. HHS’s February 2026 referral was announced publicly rather than through a charging document. No charges had been reported as of September 14, 2026.

Private securities litigation tied to the June 2025 partnership collapse has also survived early procedural challenges.

What this means if you are a customer

If you are shopping, three practical points follow.

The product changed. What Hims sells for weight loss now is primarily FDA-approved branded medication. That is a meaningful upgrade in what you are getting, and it costs more.

Verify the current price yourself. Hims pricing has moved repeatedly through 2026 and varies by plan length and dose. Do not trust a price quoted in any review, including this one, without checking hims.com.

Read “clinically necessary” carefully. The settlement preserved the option to supply compounded GLP-1s when a provider deems one clinically necessary. If you are offered a compounded product, ask what specifically about your situation makes the approved version unsuitable, and ask which pharmacy is compounding it.

As always, decisions about whether a GLP-1 is appropriate for you, and which one, belong with a healthcare provider.

Sources

Questions people ask

Does Hims & Hers still sell compounded semaglutide?

Not as an advertised product. Under its March 9, 2026 settlement with Novo Nordisk, Hims agreed to stop advertising compounded GLP-1 drugs and to sell branded Wegovy and Ozempic. The company said it would still offer compounded GLP-1s where a provider determines one is clinically necessary.

Why did Novo Nordisk sue Hims & Hers?

Novo filed a patent infringement suit on February 9, 2026, alleging Hims infringed U.S. Patent 8,129,343, which covers the semaglutide molecule, through its compounded semaglutide products, and that Hims marketed those products in ways that misled consumers about their benefits and safety.

What was the $49 pill?

On February 5, 2026 Hims announced a compounded oral semaglutide product at $49 for the first month, undercutting Novo's newly launched Wegovy pill at $149 (verified 2026-09-14: the Wegovy pill is still $149 a month at the 1.5 mg starting dose through NovoCare Pharmacy, and Hims itself now sells it at that price). It was withdrawn two days later after HHS referred the company to the Department of Justice and FDA signaled enforcement.

Did Hims get an FDA warning letter?

Yes. On September 9, 2025 FDA sent Hims & Hers dba Hers a warning letter citing website claims including 'same active ingredient as Ozempic and Wegovy' and 'clinically proven ingredients' as false or misleading, making the products misbranded.

Is Hims & Hers under federal investigation?

Three matters were open as of September 2026. The company disclosed in its fiscal 2025 Form 10-K that it received a letter from the SEC's Division of Enforcement notifying it of an investigation into its public statements about compounded semaglutide. HHS said in February 2026 that it referred the company to the Department of Justice. And on July 29, 2026 the FTC, joined by Utah and Los Angeles County, sued the company in the Northern District of California over subscription billing, cancellation, and health data sharing — a case unrelated to compounding. Hims denies the FTC's allegations.

What was wrong with the Super Bowl ad?

Senators Dick Durbin and Roger Marshall wrote to FDA arguing the February 2025 ad omitted side effect, risk, and safety information that a pharmaceutical ad would normally include. Because compounded drugs are not approved products, they sit outside the usual prescription drug advertising rules.

Is Hims & Hers a legitimate company?

It is a publicly traded company with millions of subscribers that now sells FDA-approved branded GLP-1s alongside its other product lines. It also has an FDA warning letter, an SEC inquiry, a DOJ referral, a pending FTC lawsuit, and securities litigation in its recent history. Both of those things are true; weigh them yourself.

This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.