Bacteriostatic Water for Injection — Class II drug recall D-0046-2026
Ongoing recall by GenoGenix LLC, reported 2025-10-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0046-2026 |
|---|---|
| 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
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
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-0046-2026. 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.