B. Braun Lactated Ringer’s Injection, E7500, 1L recall: Products were found to contain particulate matter in solution

What the company announced

For Immediate Release - BETHLEHEM, PA – APRIL 28, 2026 – B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution.

B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. In the complaint investigations the particles were identified as cellulose and stearates with extremely low levels of inorganic materials such as copper. To date, B. Braun has not received any reports of adverse events related to this recall to date. If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death.

This product has a reasonable probability of causing 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).

The solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Lactated Ringer's Injection USP is supplied sterile and nonpyrogenic in plastic containers packaged 12 per case.

• Product Catalog Number: E7500 · NDC Number: 0264-7750-07 · Product Description: LAC RNG INJ 1L E3 · Lot Number: J4P756 · Distribution Range: 15NOV2024 – 06MAR2025 · Expiration Date: 31MAY2027 · Region Distributed: US
• Product Catalog Number: E7500 · NDC Number: 0264-7750-07 · Product Description: LAC RNG INJ 1L E3 · Lot Number: J4S843 · Distribution Range: 13JAN2025 – 15MAY2025 · Expiration Date: 31MAY2027 · Region Distributed: US

The product can be identified by product code E7500 or NDC 0264-7750-07. Product was distributed Nationwide to distributors, hospital, and healthcare facilities.

B. Braun is notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using and arrange for return of the product using the Urgent Pharmaceutical Recall Acknowledgement form provided by the company.

Consumers with questions regarding this recall can contact B. Braun’s Recalls Department at 844-903-6417 or [email protected] , Monday to Friday from 8:00 am to 5:00 pm 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 1

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.