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 recall notice · announced September 10, 2025 · B Braun Medical
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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 for recall
Presence of Particulate Matter.
Notes
Distribution: U.S.A. Nationwide
Lot/code information: Lot #: V3K770, Exp 1/31/2026
Quantity: 47,148 containers
Status: Ongoing
Products in this recall event:
- Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 (D-0627-2025)
- 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 (D-0628-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.