Class IIReported 2025-10-15

Elite Stack 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 and Medical Health Institute (MHI).

Recalled by GenoGenix LLC

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0075-2026

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.