D-0074-2026 Class II Ongoing
FDA drug recall D-0074-2026 was initiated by GenoGenix LLC on July 30, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
US Nationwide.
Code Information
All lots within expiry.