Class I (most serious) Drug D-0540-2026 Ongoing

FDA Class I recall: particulate matter in B. Braun Lactated Ringer's injection (IV) — ~95,000 units nationwide

B BRAUN MEDICAL INC ・Reported May 13, 2026

B. Braun Medical recalled Lactated Ringer's Injection (1000 mL) over the presence of particulate matter. The FDA classified it Class I. About 95,412 units are affected, distributed U.S. nationwide. Particulate in injectables can cause serious harm.

Recall overview (primary data)

ClassificationClass I (most serious)
Product typeDrug
Recalling firmB BRAUN MEDICAL INC
ReasonPresence of Particulate Matter.
DistributionU.S.A. Nationwide
Recall initiated2026-04-28

Key points

Particulate matter in B. Braun Lactated Ringer's injection (1000 mL, Rx)
FDA classified it Class I (D-0540-2026, reported May 13, 2026, ongoing)
About 95,412 units, distributed U.S. nationwide, firm-initiated (initiated April 28, 2026)
Particulate in injected/infused products can cause embolism or inflammation
Lactated Ringer's is a basic IV fluid for dehydration and volume replacement

The U.S. FDA classified B. Braun Medical's recall of Lactated Ringer's injection as Class I (recall D-0540-2026, reported May 13, 2026, status ongoing, firm-initiated).

The affected product is Lactated Ringer's Injection USP (1000 mL container, Rx only, NDC 0264-7750-07, manufactured by B. Braun Medical, Bethlehem, PA). The recall reason is the presence of particulate matter. The recall was initiated April 28, 2026, affecting about 95,412 units, distributed U.S. nationwide.

Lactated Ringer's is a basic intravenous (IV) fluid widely used for dehydration and volume replacement. Because it is administered directly into the body, particulate in the solution can cause serious harm such as vascular occlusion (embolism) or inflammation — the basis for the most serious Class I classification.

Why it matters

A U.S.-distributed Class I drug recall in a basic medical supply (IV fluid). A useful example for hospitals and pharmaceutical quality assurance of the importance of particulate control in injectables.

FAQ

What is Lactated Ringer's?

One of the most basic IV fluids, used for correcting dehydration and replacing circulating volume.

Why is particulate serious?

Because IV products enter the body directly, particulate can cause vascular occlusion (embolism) or inflammation.

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA#Recall#Drug#Class I#IV fluid#Particulate

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