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FDA warning letter · #719809

HealBerry: What the FDA Letter Means for What You Pay

Activesemaglutide
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/healberry-719809-09092025

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

  1. 1

    The following claim concerning compounded semaglutide products appears on your website:

  2. 2

    “Same active ingredient as Ozempic and Wegovy”

  3. 3

    Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is 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 HealBerry still operating?

healberry.com returned a live client-rendered site on 2026-08-09 describing itself as "HealBerry — Whole-health telehealth — weight loss, TRT/HRT, urgent care, derm, and more." The served HTML is a shell, so the check was made against the site's JavaScript bundle rather than the raw page — it carries semaglutide and tirzepatide catalogue copy, pharmacy references and pricing including $99/month, $149 and $179 tiers. That is a check of whether the site is up and trading; it is not a check of anything the letter alleges.

What this means for what you pay

The claim itself is the most common sentence in this collection and the page could have been written by any of forty others. The reason to keep it is what it shows about looking things up. A reader who finds "FDA warning letter 719809" in a search result, or in a screenshot, or quoted in someone else's write-up, has a number that points at two different companies in two different states over two different sets of words — and nothing in the number says so. The same trap catches software: any list that treats the reference number as an identifier will silently merge these two letters and attribute one company's conduct to the other. The fix is small and worth adopting: the fda.gov URL is the unique thing, and it is the one to keep. That habit is the same one this whole collection keeps asking for — check the thing itself rather than the label on it, whether the label is a number, a brand name or the word "generic". As for what FDA found here: one sentence on one page. No finding about how the product was made, what was in it, or whether it was safe, and the letter has not been closed out.

Has HealBerry 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 HealBerry 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.