Hims & Hers is the largest name in online prescriptions. It is also, as of this month, a defendant in a federal consumer-protection suit, the subject of an SEC investigation, and the recipient of three FDA warning letters in fifteen months. We wrote this down for one reason: if you are choosing who handles your prescriptions, the record should be one click away, in the regulators' own words.
Federal Trade Commission
July 29, 2026. The FTC, Utah's Division of Consumer Protection, and California (through Los Angeles County Counsel) sued Hims in federal court in San Francisco (No. 3:26-cv-07871). The complaint alleges subscriptions charged without express informed consent, misleading "free consultation" claims, and the sharing of customer data with advertising platforms through tracking pixels. (FTC complaint)
- Status: pending. Hims moved to dismiss on October 22; the hearing is January 14, 2027. Hims calls the claims baseless and had set aside about $60 million for the matter as of June 30, 2026. (Q2 2026 10-Q)
FDA
September 9, 2025. FDA sent two warning letters, one to Hims and one to Hers, saying website claims about compounded semaglutide, including "same active ingredient as Ozempic and Wegovy," were false or misleading. FDA wrote: "Your claims imply that your products are the same as an FDA-approved product when they are not." (Hims letter, Hers letter)
- Status: Hims says it responded on time. No close-out letter is posted.
December 12, 2025. FDA sent a warning letter to MedisourceRx, the outsourcing facility Hims owns, for failing to submit an adverse event report and for procedures that did not adequately define a "serious" adverse event. (Warning letter)
- Status: FDA closed it out on July 27, 2026, finding the violations adequately addressed. (Close-out)
February 6, 2026. FDA Commissioner Makary announced FDA would act to restrict the active ingredients behind non-FDA-approved GLP-1 drugs mass-marketed by companies, naming Hims & Hers. (FDA announcement)
Department of Justice and SEC
February 2026. HHS's General Counsel said HHS had referred Hims to the Department of Justice for investigation of potential violations of the Food, Drug, and Cosmetic Act and federal criminal law. The same month, the SEC's Division of Enforcement opened an investigation into Hims's public statements about compounded semaglutide. (FY2025 10-K)
- Status: no public DOJ action. The SEC investigation is open; Hims says it is cooperating.
Novo Nordisk
June 23, 2025. Novo Nordisk ended its Wegovy collaboration with Hims after about a month, saying Hims "failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of 'personalization'." (Novo statement)
February 2026. Hims launched a compounded semaglutide pill and discontinued it two days later, according to Novo. Novo then sued Hims for patent infringement (D. Del. No. 1:26-cv-00143). (Novo statement, docket)
- Status: Novo dismissed the suit on March 9, 2026, the day the two announced a new collaboration. Hims said it would stop advertising compounded GLP-1s. (Hims release)
Shareholders and customers
- Securities fraud class action (N.D. Cal. No. 25-cv-05315), over statements about the Novo relationship. Motion to dismiss hearing: November 5, 2026.
- A second securities class action (Velanki, No. 3:26-cv-09313), filed September 1, 2026, tied to the FTC suit.
- Three shareholder derivative suits against CEO Andrew Dudum and others, stayed.
- Privacy class actions (Doe, Pearson, J.I.) over the same tracking-pixel facts as the FTC suit. Pearson also pleads California's automatic renewal law.
- A February 2026 data incident: an unauthorized party reached customer-service tickets for four days. Hims says medical records were not accessed. (FY2025 10-K)
Customer complaints
Hims's Better Business Bureau profile lists 4,539 complaints in the last three years and 1,300 in the last twelve months, and carries a notice of pending government action. (BBB, read November 5, 2026)
What none of this means
None of these matters is a finding that Hims broke the law, except where a regulator's letter says so. Lawsuits are allegations. Hims disputes them, and some have been dismissed or closed. We will update this page when a status changes.
To check any online pharmacy or prescriber yourself, read how to tell if an online pharmacy is legit.
