Agency classClass IIOur severity:High FDA (Drugs)·D-0585-2025·Announced 2025-08-20

Lactated Ringer's containers may leak at a weld site

Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: an intravenous solution with no assurance of sterility because of a potential container leak, with no infection reported.

Plain-English summary

Lactated Ringer's Injection USP, L 7500, 1000 mL Excel Container, prescription only, sterile, nonpyrogenic, single dose container, from B. Braun Medical Inc. of Bethlehem, Pennsylvania, NDC 0264-7750-00, is being recalled. The action covers 74,088 containers.

The stated reason is a lack of assurance of sterility, with the potential for fluid leakage at one of the weld sites. The FDA classified the action as Class II. The source does not report any infection or injury.

Affected lots are J5C802, J5C917 and J5C918, expiring 08/31/2027. Distribution was nationwide in the US.

Facilities should identify affected stock using the NDC and lot numbers above and follow the instructions issued by B. Braun.

The recalled product

Product: LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
Brand: LACTATED RINGERS
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Intravenous solution
Hazard: sterility-assurance
container-leak
weld-defect
class-ii
Affected units: 74,088

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot #: J5C802
J5C917
J5C918
Exp. 08/31/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · LACTATED RINGERS

Severe
B. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
Severe
Lactated Ringers Injection Recalled for Particulate Matter Contamination
FDA (Drugs) · 2026-05-13
Critical
Lactated Ringer's injection containers recalled over presence of particulate matter
FDA (Drugs) · 2025-09-10
High
Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage
FDA (Drugs) · 2024-04-10
Critical
Baxter Recalls Lactated Ringers Bags Due to Metal Particulate Matter
FDA (Drugs) · 2015-07-15

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Same hazard · sterility assurance