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FDA warning letter · #717991

Zappy: What the FDA Letter Means for What You Pay

Legal name: Kare Solutions, LLC

Activesemaglutidetirzepatideliraglutide
Status

Operating

Concerns

marketing / labeling

Issued

February 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/kare-solutions-llc-dba-zappy-717991-02202026

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://zappyhealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide drug products.

  1. 1

    The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Zappy” on the pictured label, suggesting Zappy is the compounder of those drugs when in fact it is not.

  2. 2

    “Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information” [sic] “Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information” [sic] “Tirzepatide (Active Pharmaceutical Ingredient in Zepbound®)See Zepbound FDA Information” [sic]

  3. 3

    “a proven medication” “Clinically studied and shown to deliver powerful results when combined with healthy habits.”

  4. 4

    Compounded drug products are not FDA-approved. Your claims imply that your products 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

    February 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 Zappy still operating?

zappyhealth.com returned a live storefront when we checked in August 2026, advertising a programme with a published entry price and listing compounded semaglutide and tirzepatide alongside branded Wegovy and Zepbound options.

What this means for what you pay

Every other page in this collection describes a company invoking a brand. This one describes a company invoking the regulator: the listings FDA quoted sent shoppers to FDA's own information about Wegovy, Saxenda and Zepbound from beside a compounded product FDA has not reviewed. That is the most persuasive citation a page can offer and, in FDA's account, the least applicable — the linked material describes the approved drug, not the one in the cart. It is a genuinely useful thing to carry into any price comparison: a link to an authoritative source is only as relevant as the product it is attached to, and a footnote pointing at the FDA does not convert the item above it into an FDA-reviewed product.

Has Zappy 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 Zappy 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.