FDA Drug recall D-0080-2026
pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL… by Genogenix, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0080-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-30 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genogenix |
| Distribution | US |
Product
pH Buffered 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 Medical Health Institute (MHI), 10mL.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All lots within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0080-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.