FDA Drug Recall Alert – 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB®
| Date: | September 02, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Drug Recall Alert – 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® |
| Business: | Medi-Cal Managed Care/Medicare Advantage D-SNP |
On August 28, 2026, the Food and Drug Administration (FDA) released a recall announcement on 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB®.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-100-ml-150?utm_medium=email&utm_source=govdelivery
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
On August 19, 2026, Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron oxide.
Risk Statement:
Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date there have been no reports of serious injury, death or other adverse events associated with this issue.
The recalled product can be identified as follows:
| Product Description | Product Catalog Number | NDC Number | Lot Number | Expiration Date |
|---|---|---|---|---|
| B Braun 0.9% Sodium Chloride Injection USP |
S8004-5264 | 00264-1800-32 | J6b435, J6B444, J6B457 |
30APR2027 |
Product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.
B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products. Customers that have the recalled product should return to place of purchase.
What to do:
Consumers with questions regarding this recall can contact B. Braun by emailing recalls@bbraunusa.com, Monday to Friday 8:00am to 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm or or call 1-800-332-1088 to request a reporting form to submit by fax to 1-800-FDA-0178 or to send through regular mail.
Company Information:
Consumers: B. Braun | recalls@bbraunusa.com
Media: Allison Longenhagen | allison.longenhagen@bbraunusa.com
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
