B. Braun Medical Inc. issues voluntary recall of 1-L Lactated Ringer’s and saline

From August 19, 2025, the FDA announced that B. Braun Medical Inc. (B. Braun) is voluntarily recalling 2 lots of its Lactated Ringer’s Injection, USP, 1000 mL and 0.9% Sodium Chloride Injection, USP, 1000 mL to hospitals because of the presence of particulate matter in the containers.

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According to the FDA release, the company identified the lots through complaints of particulate matter in solution.¹ As of August 19, 2025, there have been no reports of serious injury, death, or other adverse events associated with the issue. However, if particulate matter is observed before use, a brief delay could occur while obtaining a replacement product. If loose particulate is infused into a patient, there is a risk the material could enter the circulatory system, potentially resulting in harm that may require additional medical intervention and could lead to permanent impairment or death.

The following products are affected by the recall, and is used as a state indication and packaged in state type of packaging, number of units, and any associated codes¹:

• Product Catalog Number E7500
  • NDC Number: 0264-7750-07
  • Product description: Lactated Ringers Injection
    USP 1000 mL
  • Lot number: J4S807
  • DistributionRange: December 26, 2024, and April 10, 2025
  • Expiration date: May 31, 2025
  • Region distributed: US
• Product catalog number: E8000
  • NDC Number: 0264-7800-09
  • Product description: 0.9% Sodium Chloride
    Injection USP 1000ML
  • Lot number: V3K770
  • DistributionRange: November 15, 2023, and September 25, 2024
  • Expiration date: January 31, 2026
  • Region distributed: US

There is a reasonable probability that the product could cause pulmonary embolism, occlusion of other blood vessels, and/or phlebitis. Foreign particles infused intravenously can also cause systemic immune activation, organ dysfunction, and hemolysis.¹

Customers and distributors of B. Braun are being notified by certified mail, and product returns are being arranged. If a distributor has an affected product, they should cease use and distribution and quarantine the product; do not destroy it. Any customers with questions about this recall should contact the B. Braun Recalls Department between 9 AM and 5 PM. EST at 844-903-6417.

Anyone who has received the product should contact their health care provider if they experience any issues that could be related to its use. Quality problems or adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

This notice was shared by the FDA’s Center for Veterinary Medicine because these products could be used in veterinary settings.

Reference

1. B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter. News release. US Food and Drug Administration. August 19, 2025. Accessed August 21, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09#recall-photos