The agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, birds insects, and other vermin.”
In a warning letter issued in June last year to MedisourceRx, a compounding pharmacy owned by Hims & Hers, the FDA cited clear violations of good manufacturing practices. The revelations, first reported Monday by STAT News, add to the troubles of the telehealth company, which has come under fire from both regulators and Novo Nordisk for selling compounded semaglutide.
An FDA inspector found that facilities for drug manufacturing, processing, packaging or storage “are not free of infestation by rodents, birds insects [sic], and other vermin,” according to an FDA inspection form. The inspector also spotted a live spider in the area where MedisourceRx produced active pharmaceutical ingredients for human drugs.
Among these products, the warning letter specified, was Hims & Hers’ compounded semaglutide injection.
The FDA also flagged a dead cricket which “was observed in the middle of the incubator room.” MedisourceRx uses these incubators for fill vials as part of the manufacturing of drugs for human use.
Aside from the infestation, the FDA inspector also noted that one patient who had taken a dose of injectable compounded semaglutide experienced severe gastrointestinal issues that necessitated “three nights of hospital stay.” MedisourceRx “has not submitted an adverse event report” as required, the letter claimed.
“Patient safety and regulatory compliance are foundational to how we operate,” a spokesperson for Hims & Hers told STAT News, which reported that the FDA sent a second letter to MedisourceRx in December 2025, which has yet to be released publicly.
The spokesperson also told STAT that the company is working on addressing the FDA’s concerns about reporting of toxicities, but insisted that the issues of infestation enumerated in the June letter no longer appear in the December communique. The spokesperson did not provide STAT a copy of this latter letter.
The last few days have been rough for Hims. The company last week launched a compounded version of oral semaglutide, triggering a firestorm of backlash from regulatory authorities and Novo Nordisk. FDA Commissioner Marty Makary said in an X post that the agency will “take swift action against companies mass-marketing illegal copycat drugs.”
Mike Stuart, general counsel for the Department of Health and Human Services, also blasted Hims’ knockoff pill, saying in a Feb. 7 X post that he has referred the matter “to the Department of Justice for investigation.”
Novo has also sued Hims for allegedly infringing on key patents protecting semaglutide. John Kuckelman, the pharma’s general counsel, said that the company could seek trebled damages that could reach “hundreds of millions” of dollars.
Editor’s Note: An earlier version of this story incorrectly identified an FDA 483 form as a warning letter. BioSpace regrets the error.
