B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Sterility assurance failure in an intravenous injection poses a direct risk of serious infection or harm if contaminated product is administered, meeting the criteria for a Severe classification even without reported illnesses.
Plain-English summary
B. Braun Medical, Inc. is recalling 0.9% Sodium Chloride Injection USP in 250 mL Excel containers due to a lack of sterility assurance caused by leaking bags. The recalled product (NDC 0264-7800-20) was distributed nationwide.
The specific lots affected are J1E086, J1E204, and J1E213 (expiring 5/31/2023), and J1H137 and J1H138 (expiring 6/30/2023). A total of 33,742 bags have been recalled.
Healthcare professionals and patients using affected lots should contact their pharmacy or healthcare provider. Patients should not use recalled bags and should return them to B. Braun Medical, Inc. or their supplier for replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Drug — Intravenous Injection
- Hazard
- sterility-compromise
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: J1E086
- J1E204
- J1E213
- Exp 5/31/2023
- J1H137
- J1H138
- Exp 6/30/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SODIUM CHLORIDE
- SevereFresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
- SevereSodium Chloride Injection Recalled for Sterility Assurance Defect
FDA (Drugs) · 2025-07-02
- ModerateSodium Chloride Irrigation Solution Recalled for Particulate Matter
FDA (Drugs) · 2025-04-16
- SevereFDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter
FDA (Drugs) · 2024-08-28
- ModerateIntravenous Sodium Chloride Injection Recalled for Incomplete Labeling and Warnings
FDA (Drugs) · 2023-08-16
Same category
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateTopCare Earwax Removal Kit Recalled for Subpotent Drug Content
FDA (Drugs) · 2026-07-22