Highest risk U.S. Food and Drug Administration

B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container recall: Presence of particulate matter identified as iron oxide

Recall published last month

Presence of particulate matter identified as iron oxide

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

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including 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

Published
September 3, 2026
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
B. Braun
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
To date there have been no reports of serious injury, death or other adverse events associated with this issue.

Products covered by this recall

0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

What the company announced

“On September 3, 2026 firm updated their press release to include additional contaminants.”

FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron oxide, inorganic, cellulose or polystyrene particulate matter.

Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including 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 there have been no reports of serious injury, death or other adverse events associated with this issue.

0.9% Sodium Chloride Injection USP, 100 mL is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration and is packaged in non-PVC, non-DEHP flexible container system. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

The recalled product can be identified as follows:

  • Product Description: B Braun 0.9% Sodium Chloride Injection USP · Product Catalog Number: S8004-5264 · NDC Number: 0264- 1800 32 · Lot Number: J6B435 · Expiration Date: 30APR2027
  • Product Description: J6B444
  • Product Description: J6B457

Product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.

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 may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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.

  • 0.9
  • J6B435

Best-by / use-by date

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

  • 30APR2027

Package size

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

  • 100 mL
  • 150 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 — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products.

Company contact: B. Braun Medical Inc. — Consumers: B. Braun, [email protected] — Media: Allison Longenhagen, [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 as iron oxide Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including 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 0.9, J6B435; best-by date 30APR2027. 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: Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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