GenoGenix

• Pharmacy Profile Name: GenoGenix, LLC
• Website: shop.genogenix.com
• Manufacturing Location: Boca Raton, FL
• Pharmacy Type: 503B outsourcing facility
• GLP-1 Products: Semaglutide, Tirzepatide, Retatrutide
• Associated Branding: Some products labeled as manufactured for Synergy Wellness

About the Pharmacy

GenoGenix describes itself as a 503B outsourcing facility supplying doctors’ offices, med spas, clinics, and other businesses with various nutraceuticals and skincare products. It operates on a B2B model, selling to healthcare businesses rather than directly to patients. During the GLP-1 shortage era, GenoGenix became a supplier of compounded semaglutide, tirzepatide, and other injectable compounds to practices and telehealth-adjacent businesses.

GenoGenix is not a pharmacy patients would typically encounter by name. Its products have reached patients through the medical practices, clinics, and med spas that purchased from it wholesale. Some GenoGenix products were labeled as manufactured for Synergy Wellness, a white-label arrangement that means patients may have received GenoGenix-sourced products without knowing the originating manufacturer.

GLP-1 Compounding

GenoGenix’s recalled product scope included 10 mL vials of Tirzepatide 60 mg/10 mL for injection, 10 mL multi-dose vials of Semaglutide 20 mg/mL, Semaglutide with Vitamin B12 for injection across all strengths, and 54 additional compounded sterile injectable products including amino-acid blends, vitamin D-3, Lipo MIC + B12 Methylcobalamin, and other vitamin and wellness injections.

The FDA’s enforcement action against GenoGenix identified multiple serious violations that go beyond the GLP-1 marketing claims that characterized most of the March 2026 warning letter batch.

Regulatory History

GenoGenix’s enforcement record is among the most serious in this pharmacy review series:

Sterility Recall: GenoGenix initiated a recall across 56+ product categories due to lack of assurance of sterility.

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FDA Warning Letter — February/March 2026: The FDA accused GenoGenix of repackaging semaglutide, tirzepatide, and retatrutide — retatrutide being a next-generation GLP-1 medicine still in clinical trials at Eli Lilly that cannot legally be compounded.

Three ER Visits: Three people were directed to the emergency room after taking products compounded by GenoGenix. The FDA documented these incidents in the warning letter. The patients experienced low blood pressure, uncontrollable shaking, shivers, and body aches. An FDA analysis of an unopened vial from the same lot found excessive bacterial endotoxins.

Illegal Substance Compounding: FDA inspectors found that GenoGenix compounded medicines including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+), which are ineligible for exemptions under Section 503B.

Manufacturing Deficiencies: FDA inspectors found fault with manufacturing practices at GenoGenix’s facility, including unsanitary conditions and operational practices that could compromise aseptic processing. Inspectors observed personnel failing to disinfect materials and engaging in aseptic processing while exposing skin, plus facility design that could compromise cleanroom integrity.

Illegal Retatrutide Compounding: Retatrutide — included among GenoGenix’s recalled products — is an experimental Eli Lilly obesity drug still in clinical trials. The FDA explicitly warns that retatrutide cannot be legally compounded because it is not on the FDA’s compounding bulks list and has no approved formulation.

Type of Pharmacy

GenoGenix registered as a 503B outsourcing facility — the higher-scrutiny tier of compounding that requires FDA registration, cGMP compliance, and regular inspections. The violations documented during the FDA’s inspection are therefore particularly significant, as the 503B designation carries explicit federal oversight obligations that GenoGenix failed to meet across multiple categories.

States Licensed In

GenoGenix operated as a wholesale supplier to clinics and med spas nationally. Its specific multi-state licensing footprint is not publicly confirmed. Current operational status following the recall and Warning Letter is unconfirmed as of March 2026.

Telehealth Providers They Work With

No specific telehealth platform partnerships for GenoGenix were identified in public records. Its B2B model served medical practices, med spas, and clinics directly rather than named telehealth platforms. Some products were labeled as manufactured for Synergy Wellness, indicating a white-label supply relationship with at least one downstream brand.

Pricing from Reviews

GenoGenix operated as a wholesale supplier — pricing was set at the business-to-business level and is not reflected in public consumer pricing data.

Overall Reviews

GenoGenix does not have a meaningful consumer-facing review profile. Its B2B model means patients who received its products were generally unaware of the originating manufacturer. The enforcement record that emerged in early 2026 — three documented ER visits from a bacterially contaminated product, a sterility recall covering 56+ product types, the illegal compounding of retatrutide, and unsanitary aseptic processing conditions documented by FDA inspectors — represents the most serious patient safety record of any pharmacy covered in this review series to date.