FDA recall D-0075-2026

GenoGenix LLC · Class II · drug

Product

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).

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-07-30
Report date
2025-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2026