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FDA warning letter · #728275

AM RX: What the FDA Letter Means for What You Pay

Legal name: FitRX, LLC

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

June 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-am-rx-728275-06082026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

Violations were identified and documented during a review of AM RX’s website, https://getamrx.com, FDA Establishment Identifier (FEI) 3044021238, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.

  1. 1

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

  2. 2

    “AM Rx also offers semaglutide, the active ingredient in Ozempic® and Wegovy®….”

  3. 3

    “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.”

  4. 4

    Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer 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

    June 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 AM RX still operating?

getamrx.com returned a live storefront when we checked in August 2026, offering weight loss, mental health, primary care, birth control, erectile dysfunction, hair loss and skincare, and promoting a discount on its weight-loss programme. The homepage also carried the line "Your Zealthy treatment plan starts here" — Zealthy being another FitRX, LLC brand that received its own FDA letter in September 2025.

What this means for what you pay

Here the brand architecture shows through the paintwork. FitRX, LLC has been written to by FDA three times, once in each telehealth wave, under three different storefront names — and when we opened the AM Rx site in August 2026 the page told us our "Zealthy treatment plan" was starting, naming a sibling brand outright. So the connection is not an inference from a shared template; it is on FDA's letterheads and on the company's own homepage. Why this belongs on a pricing page: shoppers compare brands, and brands are cheap to create. Three storefronts with three price lists can look like a competitive market and be one operator's catalogue, in which case the spread between them tells you about positioning rather than about who is genuinely cheapest. None of the three letters alleges anything about the medication itself, and none is a shutdown. They are letters about advertising copy — but read together they tell you something the copy does not, which is how few companies are behind the names.

Has AM RX 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 AM RX 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.