Hims Halts Semaglutide Pill After FDA Warning
Hims Halts Semaglutide Pill as Hims & Hers stopped sales after an FDA enforcement warning on unapproved compounded GLP-1s, raising risk for DTC health stocks.
KEY TAKEAWAYS
- Hims halted sales of a compounded semaglutide pill after an FDA warning.
- The product was marketed as a Wegovy copycat and priced at $49 per month.
- FDA recorded 605 adverse-event reports for compounded semaglutide and added GLP-1 APIs to import alerts.
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Hims & Hers halted sales of its compounded semaglutide pill days after launching the product, following an FDA warning about unapproved GLP-1 drugs and related safety concerns.
Sales Halt and Product Launch
Hims & Hers launched an oral, once-a-day compounded semaglutide pill on February 5, 2026. The company positioned the product as an oral alternative to Novo Nordisk’s Wegovy injectable, marketing it as a Wegovy copycat for weight loss. The introductory price was $49 per month.
On February 7, 2026, at 14:18 ET, Hims announced it would stop offering the treatment, citing constructive conversations with industry stakeholders. The rapid launch and withdrawal highlight challenges direct-to-consumer health companies face when introducing novel compounded formulations.
FDA Safety Concerns and Enforcement Actions
The FDA states that compounded GLP-1 drugs are not approved and do not undergo agency review for safety, effectiveness, or quality before marketing. The agency has flagged risks including dosing errors linked to adverse events and hospitalizations, improper shipping and storage, fraudulent products, and the use of non-equivalent salt forms such as semaglutide sodium or acetate. Unauthorized agents like retatrutide and cagrilintide have also appeared in some formulations.
As of July 31, 2025, the FDA’s safety database recorded 605 adverse-event reports related to compounded semaglutide and 545 reports tied to tirzepatide. To tighten supply-chain controls, the FDA added non-compliant GLP-1 active pharmaceutical ingredients to import-alert green list 66-80, blocking shipments at the border. The agency pledged to use all available compliance and enforcement tools.
The Department of Health and Human Services said it would refer the matter involving Hims to the Department of Justice.
This enforcement posture, combined with the adverse-event record and import restrictions, significantly increases regulatory risks for direct-to-consumer companies marketing compounded GLP-1 products. It may also limit similar product launches in the sector.
"Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed," the FDA said.
