0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
FDA recall notice · announced July 2, 2025 · B Braun Medical
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reason for recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Notes
Distribution: USA Nationwide
Lot/code information: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Quantity: 187,656 containers
Status: Ongoing
Products in this recall event:
- 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. (D-0491-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.