FDA Recall D-0627-2025

B BRAUN MEDICAL INC · Allentown, PA

Class I — life-threatening Ongoing 269 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

Lot / code: Lot #: J4S807, Exp 5/31/2027

Quantity: 46,032 containers

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-0627-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2025-08-18
Classified by FDA Center: 2025-09-10
FDA published: 2025-09-10
Recalling firm: B BRAUN MEDICAL INC
Firm location: Allentown, PA

Drug identification

Brand name(s): LACTATED RINGERS
Generic name(s): SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE
Manufacturer(s): B. Braun Medical Inc.
NDC(s): 0264-7750
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls