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FDA warning letter · #716488

Reset IV: What the FDA Letter Means for What You Pay

Legal name: Reset IV, LLC

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

September 2025

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/reset-iv-llc-dba-reset-iv-716488-09092025

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://resetiv.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.

  1. 1

    "Semaglutide (the same ingredient in Wegovy & Ozempic)"

  2. 2

    "Tirzepatide (the same ingredient in Zepbound & Mounjaro)"

  3. 3

    Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    September 2025

  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 Reset IV still operating?

resetiv.com returned a live storefront when we checked in August 2026, still trading as a Las Vegas mobile IV therapy service with published package pricing. Neither semaglutide nor tirzepatide appeared on its homepage or its peptide-therapy page at that check, though we did not review every page on the site, so this is not a confirmation that the products named in the letter were withdrawn.

What this means for what you pay

This letter is the useful counter-example to the assumption that a warning letter marks out a bad actor. Nothing here concerns pricing, nothing concerns safety, and nothing concerns a claim anyone wrote as a sales pitch — FDA cited two parentheses in two product names, the sort of shorthand a shopper would read as a helpful clarification rather than a claim. It is a reminder that the presence of a letter tells you what wording FDA reviewed in one month of 2025, not how a company operates. It also shows how wide this enforcement wave was cast: a regional IV-drip service got the same letter, from the same office, on the same day as the largest telehealth brands in the country.

Has Reset IV 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 Reset IV failed to respond.

Sources

Other letters in this index

View the full index →

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.