Serious health risk
⚠ This recall is currently active
GenoGenix LLC
Drugs recall · D-0081-2026
Reason for recall
Lack of Assurance of Sterility
Product description
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.
Recalling firm
GenoGenix LLC
Lot / code info
All lots within expiry.
Distribution
US Nationwide.
Recall initiated
2025-07-30
Status
Ongoing
Location
Boca Raton, FL, United States
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Data from official federal safety records. Updated periodically. Verify on FDA.gov