Hims & Hers Faces Escalating FDA Scrutiny Over Compounding Pharmacy Violations and Semaglutide Products

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FDA issued a warning letter in June 2025 to MedisourceRx, a compounding pharmacy owned by Hims & Hers, citing violations including facility infestation by rodents, birds, insects, a live spider, and a dead cricket in production areas used for compounded semaglutide.123

MedisourceRx failed to report a serious adverse event in January 2025 where a patient experienced severe gastrointestinal issues requiring three nights in hospital after taking compounded injectable semaglutide.123

A second FDA warning letter was issued to MedisourceRx on December 12, 2025, not yet public, addressing ongoing issues like adverse event reporting.13

In September 2025, FDA warned Hims & Hers for misleading website claims about compounded semaglutide implying equivalence to FDA-approved Ozempic and Wegovy.5

Hims & Hers launched a compounded oral semaglutide pill on February 5, 2026, prompting backlash from Novo Nordisk and FDA; the company ceased offering it by February 7, 2026, amid FDA's February 6 announcement to restrict GLP-1 ingredients in mass-marketed compounded drugs.468

HHS General Counsel referred Hims & Hers to DOJ on February 6, 2026, for potential federal law violations related to compounded GLP-1 products.4

Sources:

1. https://www.biospace.com/fda/hims-hers-woes-compound-as-fda-hits-company-with-warning-letter

2. https://www.statnews.com/pharmalot/2026/02/10/trump-340b-antibiotics-hims-fda-rare-disease-animals/

3. https://www.statnews.com/pharmalot/2026/02/09/fda-inspection-warns-hims-compounder-bugs-wegovy/

4. https://natlawreview.com/article/fda-tightens-belt-glp-1-compounding-escalating-threat-enforcement

5. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hers-09092025

6. https://www.pharmexec.com/view/hims-hers-pulls-access-compounded-semaglutide-pill-following-controversial-launch

8. https://www.nasdaq.com/articles/hims-hers-collapses-after-fda-vows-restrict-copycat-glp-1-pill-stock-toast