FDA Drug recall D-0628-2025
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
- FDA Drug
- Class I
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class I recall of 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 by B Braun Medical, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0628-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Reason
Presence of Particulate Matter.
Identifiers
| ndc | 0264-7800-09 |
|---|---|
| code_info | Lot #: V3K770, Exp 1/31/2026 |
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-0628-2025%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.