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FDA warning letter · #717987

FitRx: What the FDA Letter Means for What You Pay

Legal name: FitRX, LLC

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

February 2026

Response logged

Not logged

By Marla Whitfield, Pricing Editor

Primary source

Read the original letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitrx-llc-dba-fitrx-717987-02202026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.fitrxapp.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.

  1. 1

    The compounded semaglutide and tirzepatide products displayed on your website identify “FitRx” on the pictured label, suggesting FitRx is the compounder of those drugs when in fact it is not.

  2. 2

    “we can ship semaglutide, the main active ingredient in Wegovy and Ozempic, or Tirzepatide, the main active ingredient in Zepbound and Mounjaro”

  3. 3

    Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    February 2026

  2. 2

    15-working-day response window

    FDA gives the company 15 working days to respond in writing.

  3. 3

    Close-out, if issued

    FDA may post one once it is satisfied the cited issues have been corrected.

Is FitRx still operating?

fitrxapp.com returned a live storefront when we checked in August 2026, covering weight loss, hair loss, birth control, mental health, skincare, enclomiphene and erectile dysfunction. We did not review every page on the site.

What this means for what you pay

The interesting fact about this letter is not the copy — it is the letterhead. FitRX, LLC is named in FDA's database three separate times across the three telehealth waves, once as Zealthy in September 2025, once as FitRx here, and once as AM RX in June 2026. One company, three storefronts, three letters. That is worth knowing when you are shopping, because a comparison table treats brands as competitors: you can line up three prices, feel you have surveyed the market, and be looking at one operator throughout. The letters themselves remain narrow — cited marketing phrases, no finding about the medication, no shutdown, and receiving several is not itself evidence of anything worse than operating several sites. But the brand names are not independent data points, and if you are checking a company's regulatory record, the name on the homepage is not always the name FDA wrote to.

Has FitRx responded?

As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence FitRx failed to respond.

Sources

Other letters in this index

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Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.