Injection Recall: GenoGenix Ultra Burn for Injection
Announced 2025-10-15 · FDA
The recall involves Ultra Burn for Injection from GenoGenix LLC (all strengths and presentations) distributed nationwide in the United States. The recall is issued for lack of assurance of sterility; all lots within expiry are included. No corrective action is specified in the provided information.
| Brand | GenoGenix LLC |
|---|---|
| Product | Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 12 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | All lots within expiry. |
WHAT YOU SHOULD DO
- Do not use Ultra Burn for Injection from this recall.
- Contact your healthcare provider or supplier for guidance and replacement options.
- If you have stock, isolate it and contact GenoGenix or the FDA for disposal/return guidance.
- Monitor recall updates from the FDA for additional guidance.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.