FDA Drug recall D-0495-2026
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7… by B Braun Medical, citing lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0495-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Identifiers
| ndc | 0264-7385-50 |
|---|---|
| ndc | 0264-7385-60 |
| code_info | Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0495-2026%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.