GenoGenix LLC recalls Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW
Recalled October 15, 2025 · FDA recall D-0074-2026 · GenoGenix
Hazard
Lack of Assurance of Sterility · FDA Class II
Sold at
US Nationwide.
Description
Lack of Assurance of Sterility
Product
Elite Stack MSC Exosome Reconstitution 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 Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.
Manufacturer(s)
GenoGenix LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →