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FDA warning letter · #715801

Get.Fit.Medical: What the FDA Letter Means for What You Pay

Legal name: Get.Fit.Medical, LLC

Activesildenafiltadalafilsemaglutidetirzepatide
Status

Unknown

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/getfitmedical-llc-dba-getfitmedical-715801-09092025

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://www.getfitmedical.com in August 2025 and has observed that your website offers various compounded drug products, including sildenafil, tadalafil, semaglutide, and tirzepatide. As described below, your claims concerning compounded sildenafil, tadalafil, semaglutide, and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].

  1. 1

    The following claims concerning compounded sildenafil, tadalafil, semaglutide, and tirzepatide products appear on webpages that offer only compounded products: • “SILDENAFIL (GENERIC VIAGRA)” • “TADALAFIL (GENERIC CIALIS)” • “SEMAGLUTIDE (GENERIC OZEMPIC/WEGOVY)” • “TIRZEPATIDE (GENERIC MOUNJARO)”

  2. 2

    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. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].

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 Get.Fit.Medical still operating?

getfitmedical.com resolved on 2026-08-09 but returned HTTP 404 with a page titled "Squarespace - Website Expired" on both the apex and www hosts — the hosting subscription has lapsed, so no storefront is reachable. An expired site plan is not evidence a business has closed: it can be renewed, and a company can move platforms. Recorded as unknown rather than ceased-operations.

What this means for what you pay

Four products, two categories, one template — and that is the point. This site was not making an argument about semaglutide; it was applying a formatting rule, "MOLECULE (GENERIC BRAND)", to everything on the shelf. Whoever built those pages appears to have treated "generic" as the ordinary retail word for a cheaper version of a familiar drug, which is how it works at a pharmacy counter and is not how it works here: a generic is an FDA-approved copy of an approved drug, and none of these four had one. Sildenafil and tadalafil are the interesting case, because generic sildenafil and generic tadalafil genuinely exist as approved products — so the same phrase is accurate at a pharmacy and inaccurate on a page that ships compounded material. That is a distinction a shopper comparing prices has almost no way to see, and it is why the price gap between a "generic" at a pharmacy and a "generic" on a telehealth storefront can be so wide. FDA's qualifier does the work: the pages in question "offer only compounded products", so nothing on them could have been the generic the label promised. The site itself is no longer reachable — its Squarespace subscription has expired.

Has Get.Fit.Medical 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 Get.Fit.Medical failed to respond.

Sources

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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.