Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Reconstitution XO Solution for Injection Recalled by GenoGenix LLC Due to Lack of Assurance of Sterility

Date: July 30, 2025
Company: GenoGenix LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GenoGenix LLC directly.

Affected Products

Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GenoGenix LLC

GenoGenix LLC has 57 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report