GenoGenix LLC recalls Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca
Recalled October 15, 2025 · FDA recall D-0081-2026 · GenoGenix
Hazard
Lack of Assurance of Sterility · FDA Class II
Sold at
US Nationwide.
Description
Lack of Assurance of Sterility
Product
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.
Manufacturer(s)
GenoGenix LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →