FDA Drug recall D-0089-2026
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extens…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extens… by Genogenix, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0089-2026 |
| 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
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot#: GG053025-002 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-0089-2026%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.