Sterile Saline Reconstitution Solution for Injection — Class II drug recall D-0082-2026
Ongoing recall by GenoGenix LLC, reported 2025-10-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0082-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GenoGenix LLC, Boca Raton, FL, United States |
| Recall initiated | 2025-07-30 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
Sterile Saline Reconstitution Solution 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0082-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.