# GenoGenix

> Source: https://peptidewellnessusa.com/professionals/compounding-pharmacies/genogenix/

A Florida peptide/GLP-1/NAD+ 503B that sold to med spas and clinics — and the subject of a January 2026 FDA warning letter. A cautionary case for the category.

We include GenoGenix not as a recommendation but as a documented cautionary case: a peptide-heavy 503B whose FDA inspection surfaced exactly the risks the peptide gray market is warned about — ineligible bulk substances, sterility/endotoxin failures, and sub-potent products.

## Facility & compounding

GenoGenix (Boca Raton, FL) is on the FDA Registered Outsourcing Facilities list [2] and marketed itself as a 503B supplying doctors’ offices, med spas, and clinics [3]. Its catalog was peptide-heavy — dozens of lyophilized peptides and nasal sprays. Per FDA’s warning letter, products included peptides such as Epithalon, Thymosin Beta-4, and 5-Amino-1MQ; NAD+; and repackaged GLP-1s (semaglutide, tirzepatide, retatrutide) [1]. Accreditation: no PCAB listing was found in ACHC’s directory.

## Regulatory record

This is the core of the profile, and every fact here is from FDA’s own warning letter (#718739, dated January 20, 2026), which followed a July 14–18, 2025 inspection [1]. Per that letter, FDA cited:

- compounding with **bulk drug substances not eligible** for 503B use (5-Amino-1MQ, NAD+);
- **insanitary conditions and aseptic-processing / CGMP violations**;
- **sub-potent products** (methylcobalamin measured at 65.3% of label; a B-complex product at 43.1%);
- a **NAD+ lot with 3,360 EU/mL of endotoxin** that FDA links to **three patients sent to the emergency room**;
- repackaged GLP-1s and Thymosin Beta-4 handled as unapproved new drugs.

FDA states the firm ceased production/distribution and initiated a voluntary recall on July 30, 2025 [1]. These are FDA’s inspection findings as stated in the warning letter, dated to our review.

## The read

GenoGenix is the concrete version of the warning we give across this site about gray-market peptide sourcing: when a compounder uses ineligible bulk substances and its sterility controls fail, real patients can be harmed. It belongs in this directory for completeness and as a caution — not as an endorsement. Anyone evaluating a peptide compounder should treat a record like this as disqualifying until independently resolved.

## References

1. [FDA — Warning Letter to GenoGenix LLC (#718739, 2026-01-20).](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genogenix-llc-718739-01202026) (accessed 2026-07-01)
2. [FDA — Registered Outsourcing Facilities (503B) list.](https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities) (accessed 2026-07-01)
3. [GenoGenix — product storefront.](https://shop.genogenix.com/) (accessed 2026-07-01)