FDA Recall of B. Braun 0.9 % Sodium Chloride Injection Over Zinc-Oxide Particulates
The U.S. Food & Drug Administration (FDA) has announced a nationwide recall of three lots of B. Braun 0.9 % Sodium Chloride Injection USP, 100 mL in a 150 mL PAB® container, after visible zinc-oxide particles were found in the solution. Infusing contaminated IV saline can cause life-threatening emboli and other serious complications, so healthcare facilities must stop using and return the affected product immediately.
Key Recall Details at a Glance
- Recall date: August 28, 2026 (FDA bulletin)
- Manufacturer: B. Braun Medical Inc. — Bethlehem, Pennsylvania
- Product: 0.9 % Sodium Chloride Injection USP, 100 mL IV bag (prescription drug)
- Reason: Particulate contamination (zinc-oxide)
- Distribution period: February 27 – August 3, 2026 (U.S. hospitals and clinics)
Affected Catalog & Lot Numbers
Quarantine and return the specific catalog, NDC, and lot numbers listed below:
| Catalog # | NDC | Lot # | Expiration |
|---|---|---|---|
| S8004-5264 | 0264-1800-32 | J6B435 | 30-Apr-2027 |
| S8004-5264 | 0264-1800-32 | J6B444 | 30-Apr-2027 |
| S8004-5264 | 0264-1800-32 | J6B457 | 30-Apr-2027 |
Health Dangers of Particles in IV Saline
Injecting particulate matter directly into the bloodstream can result in:
- Pulmonary or systemic emboli that block blood flow
- Ischemia or tissue/organ damage from vessel occlusion
- Phlebitis and potential clot formation at the infusion site
- Immune and inflammatory reactions leading to hemolysis or organ dysfunction
No injuries have been reported so far, but the possibility of severe harm warrants immediate product removal.
Required Actions for Hospitals & Clinicians
- Isolate and label all inventory that matches the lot numbers above.
- Arrange a return through your distributor or directly with B. Braun for replacement credit.
- Update pharmacy dispensing systems and alert clinical staff to prevent administration.
- Report any adverse events to FDA MedWatch:
- Direct questions to B. Braun at recalls@bbraunusa.com (Mon–Fri, 8 AM – 5 PM ET).
Official Recall Image
Frequently Asked Questions
1. Why is B. Braun 0.9 % Sodium Chloride Injection being recalled?
The recall was issued because zinc-oxide particles were detected in three production lots, posing a risk of emboli and other severe reactions if infused.
2. Which lot numbers of B. Braun 0.9 % Sodium Chloride Injection are affected?
Lots J6B435, J6B444, and J6B457 (catalog S8004-5264, NDC 0264-1800-32) are included in the 2026 FDA recall.
3. What actions should hospitals take for the B. Braun sodium chloride recall?
Immediately quarantine the recalled IV bags, arrange return processing with the distributor or B. Braun, update pharmacy systems, and notify all clinical staff.
4. Have any adverse events been linked to the B. Braun saline recall?
No injuries or deaths were reported to FDA as of the August 28, 2026 notice, but facilities should still monitor patients and report issues.
5. How do I return B. Braun 0.9 % Sodium Chloride Injection and obtain credit?
Contact your distributor or email recalls@bbraunusa.com with purchase details; B. Braun will provide shipping labels and replacement or credit instructions.
6. Is it safe to use other lot numbers of B. Braun 0.9 % Sodium Chloride Injection?
Yes. Only the three specified lots are recalled. Other lots that are clear, particle-free, and within expiration can continue to be used per normal protocols.
7. How do I report a problem with B. Braun 0.9 % Sodium Chloride Injection to FDA?
Submit a report through the FDA MedWatch portal or by using the downloadable form found on the FDA’s MedWatch website (links above).