Elite Stack MSC Exosome Reconstitution Solution for Injection recalled over sterility concerns

Recall date

July 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GenoGenix LLC recalls Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW…

Recall number

D-0074-2026

FDA classification

Class II

Brand / firm

GenoGenix LLC

Sold / distributed

US Nationwide.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.