FDA Recall D-0068-2026
GenoGenix LLC · Boca Raton, FL
Class II Ongoing 288 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0068-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2025-07-30
- Classified by FDA Center
- 2025-10-21
- FDA published
- 2025-10-15
- Recalling firm
- GenoGenix LLC
- Firm location
- Boca Raton, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.