B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution
B. Braun Medical Inc. has initiated a voluntary nationwide recall of two lots of Lactated Ringer’s Injection (E7500, 1L) due to the presence of particulate matter identified in the solution. The recall is conducted at the hospital and healthcare facility level.
This affects B. Braun Medical Inc., hospital pharmacies, healthcare facilities, and clinical staff responsible for the administration of intravenous fluids.
The presence of particulate matter in sterile injectable drugs represents a significant safety risk, potentially leading to embolic events or systemic inflammatory responses if administered. This recall suggests a potential breakdown in the manufacturing or primary packaging integrity for these specific lots. Regulatory and QA teams should view this as a trigger for evaluating visual inspection protocols and supplier quality oversight for container closure systems.
Immediately quarantine and discontinue use of the specified lots. Facilities should audit inventory for Lactated Ringer’s Injection USP (E7500, 1L) and initiate reconciliation procedures as per the voluntary recall notice. Quality units should monitor for any adverse event reports related to particulate matter.
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.
Open in openFDA / FDA.gov