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FDA Warning Letter · #721709

PekCura Labs — FDA Warning Letter (March 31, 2026)

Issued March 31, 2026Status: activeCenter for Drug Evaluation and Research (CDER)

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026

Summary

Company
PekCura Labs
Letter number
#721709
Issue date
March 31, 2026
Subject
Unapproved New Drugs Sold Over the Internet

What FDA cited

The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

How this letter sits against the other 157

Our reading, from the 158 letters on this register — not part of the FDA’s document.

5 letters on this register carry the date March 31, 2026, so this was a small group action rather than a mass sweep.

A warning letter is the agency putting a company on notice, not a court finding and not a ban. What it is worth to you is in what it alleges, so read the original on fda.gov rather than the fact that one exists.

From the letter

Read full letter on FDA.gov →

Word for word, from the letter of March 31, 2026

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pekcuralabs.com/ in January 2026. The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.

Despite statements on your product labeling marketing your products for “Research, [sic] Development [sic] use only” and “are Not [sic] for Human [sic] consumption of any kind,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.

Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

GLP-1-S (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-1-s-5mg/, https://pekcuralabs.com/shop/pcl-glp-1-s/, https://pekcuralabs.com/shop/gmp-pcl-glp-1-s/, and https://pekcuralabs.com/shop/gmp-pcl-glp-1-s-5mg/:

GLP-2-T (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-2-t-10mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-15mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-30mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-60mg/, https://pekcuralabs.com/shop/gmp-pclglp-2-t-15mg/, and https://pekcuralabs.com/shop/gmp-pcl-glp-2-t/:

GLP-3-R (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-3-r-10mg/ and https://pekcuralabs.com/shop/gmp-pcl-glp-3-r-30mg/:

Bacteriostatic Water (all variations)Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026

What FDA warning letters mean

It is the agency writing to a company to say it believes something that company is doing breaks the Federal Food, Drug, and Cosmetic Act — usually a claim on a website, a labeling choice, or how a drug is being made. The company has about fifteen working days to write back.

Read carefully what it is not. It is not a recall, not a criminal charge, and not a court deciding anyone broke the law. It is the regulator opening a file. Companies frequently answer a letter, fix what was cited, and carry on trading, and when FDA accepts that it can issue a close-out letter. We do not track close-outs, so the presence of a letter on this page tells you what FDA said on one date — not where the matter stands today. Ask the company; they will usually tell you, and how they answer is informative in itself.

Across this market the same three citations recur: claiming a compounded product is equivalent to an approved one, labeling that misleads, and compounding from bulk substances FDA has not cleared under sections 503A and 503B. If you are reading a letter here, it is probably one of those.

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Editorial Disclaimer

This is a public communication from a regulator, and by itself it settles nothing about whether the company broke any law. Corrective action is a common response, and a fair number of letters end in a close-out. Read the whole thing on fda.gov through the link above rather than taking our excerpt as the full picture.

Glossary

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