Agency classClass IOur severity:Critical FDA (Drugs)·D-0627-2025·Announced 2025-09-10

Lactated Ringer's injection containers recalled over presence of particulate matter

B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this particulate matter action as Class I.

Plain-English summary

Lactated Ringer's Injection USP in 1000 mL containers, available on prescription only, from B. Braun Medical, Inc. of Bethlehem, Pennsylvania, NDC 0264-7750-07, is being recalled. The affected product is lot J4S807 with an expiry of 5/31/2027, and the recall covers 46,032 containers distributed nationwide.

The recall was issued for the presence of particulate matter. The FDA classified the action as Class I, its most serious category.

Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow B. Braun's instructions for return or replacement.

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: particulate-matter
injectable
class-i
Affected units: 46,032

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 (2)

Lot #: J4S807
Exp 5/31/2027

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 →

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