Class I U.S. Food and Drug Administration

B. Braun Excel® Lactated Ringers Injection, 1000mL recall: Presence of particulate matter identified primarily as cellulose cotton

Recall published 2 months ago

Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene

B. Braun Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting).

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0832-2026
Published
August 19, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B. Braun
Product type
Prescription & OTC drugs
Units affected
23,688 bags
Distribution
Nationwide
Lot / code info
Lot#: J4H077, Exp 30NOV2026.

Products covered by this recall

Excel® Lactated Ringers Injection, 1000mL

What the company announced

FOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) , is voluntarily recalling one lot of Excel® Lactated Ringers Injection, 1000mL to the hospital/healthcare facility level, due to the presence of particulate matter in solution identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene.

Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date, B. Braun has not received any reports of adverse events related to this recall.

The product is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need and is packaged in non-PVC, non-DEHP flexible container system. Product was distributed Nationwide and to Canada to hospitals and healthcare facilities from August 29, 2024, through September 30, 2024.

The recalled product can be identified as follows:

  • Product Description: B. Braun Excel® Container Lactated Ringers Injection, 1000ml · Product Catalog Number: L7500 · NDC Number: 0264-7750-00 · Lot Number: J4H077 · Expiration Date: 30NOV2026

B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products.

Customers that have the recalled product should return to place of purchase.

Consumers with questions regarding this recall can contact B. Braun by emailing [email protected] , Monday to Friday 8:00am to 5:00pm EST . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Adverse reactions or quality problems experienced with the use of this product in an off label manner for animal/veterinary patients may be reported to the FDA online at http://www.FDA.gov/reportanimalAE

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • J4H077

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 30NOV2026. B
  • 30NOV2026

NDC number

On the carton and again on the bottle or blister label.

  • 0264-7750-00

Package size

Match the net weight or the piece count on the front of the pack.

  • 1000 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

B. Braun — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Remedy named in the notice: The product is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need and is packaged in non-PVC, non-DEHP flexible container system.

Company contact: (B. Braun) — Consumers: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B. Braun prescription & otc drugs recalled?

Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code J4H077; best-by date 30NOV2026. B or 30NOV2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: The product is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need and is packaged in non-PVC, non-DEHP flexible container system.

Where was the recalled product sold?

It was distributed nationwide.

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