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FDA warning letter · #728238

D&H Medical Services: What the FDA Letter Means for What You Pay

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/dh-medical-services-728238-06082026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

Violations were identified and documented during a review of D&H Medical Services’ website, https://www.dhmedicalcenter.com, FDA Establishment Identifier (FEI) 3044174854, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.

  1. 1

    1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:

  2. 2

    “Same ingredient as Ozempic®”

  3. 3

    “Same ingredient as Rybelsus®”

  4. 4

    “Same ingredient as Mounjaro®”

  5. 5

    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 D&H Medical Services still operating?

dhmedicalcenter.com returned a live site on 2026-08-09 titled "D&H Medical Center | Miami | 2500 Northwest 79th Avenue, Doral, FL, USA", presenting a bricks-and-mortar clinic — primary care, weight loss, NAD+ and IV infusions, pre-surgery clearance — with a published Miami phone number (786.375.6210) and a client log-in. That is a check of whether the site is up; it is not a check of anything the letter alleges.

What this means for what you pay

Rybelsus is why this one is worth reading. The other letters compare an injection to an injection, which at least keeps the argument inside one dosage form. Here the same six-word template was applied to a tablet, and a tablet is where "same ingredient" quietly stops meaning very much: Rybelsus is oral semaglutide formulated with an absorption enhancer precisely because semaglutide on its own barely survives the gut, and the approval that exists is for that formulation, not for the molecule in the abstract. Note also what the sentence left out. Every other seller in this collection wrote "same ACTIVE ingredient"; this one wrote "same ingredient", which is a broader statement, not a narrower one — a finished drug is an active ingredient plus everything else, and the everything else is what an approval covers. The useful question a shopper can actually ask is therefore not "is it the same molecule" but "same as WHAT, exactly — the same route, the same formulation, the same strength, made by whom?" This is also not a telehealth-only storefront but a Doral clinic with a street address and a phone number, which makes that question askable out loud. FDA made no finding here about the products' quality or contents.

Has D&H Medical Services 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 D&H Medical Services 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.