FDA warning letter · #716488
Reset IV: What the FDA Letter Means for What You Pay
Legal name: Reset IV, LLC
Operating
marketing / labeling
September 2025
Not logged
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
“"Semaglutide (the same ingredient in Wegovy & Ozempic)"”
- 2
“"Tirzepatide (the same ingredient in Zepbound & Mounjaro)"”
- 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
Letter issued
September 2025
- 2
15-working-day response window
FDA gives the company 15 working days to respond in writing.
- 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we did not review every page on the site, so this is not a confirmation that the products named in the letter were withdrawn.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
Maximus
marketing / labeling · Issued June 2026
Ezra
marketing / labeling · Issued June 2026
Eden
marketing / labeling · Issued June 2026
Joi + Blokes
marketing / labeling · Issued June 2026
Thrivelab
marketing / labeling · Issued June 2026
MEDVi
marketing / labeling · Issued February 2026
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.