STERILE WATER FOR INJECTION USP — Class II drug recall D-0652-2025
Ongoing recall by B BRAUN MEDICAL INC, reported 2025-09-24, distributed nationwide. Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
| Recall number | D-0652-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2025-08-26 |
| Classified | 2025-09-16 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 26,316 |
| Reason classes | sterility, packaging |
| NDC | 00264-7385, 00264-7385-50, 00264-7385-60 |
| Lot numbers | J3L519, J3L528, J4C522, J4C523 |
| Expiration dates | 2026-08-31, 2027-02-28 |
Product
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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-0652-2025. 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.