Class IIReported 2025-10-15

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.

Recalled by GenoGenix LLC

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0074-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-30

Reported

2025-10-15

Distribution

US Nationwide.

Code Info

All lots within expiry.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.