0.9% Sodium Chloride Injection, Recall: Presence of Particulate Warning

October 3, 2026 — This alert was compiled from official government recall data published by the FDA. All facts are sourced directly from official records.

Stock photo for illustration — not the actual recalled product. Photo by Camila Mofsovich on Unsplash

Did you recently purchase or receive a 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container? This might seem like a minor detail in your busy life, but it's connected to a significant health alert. The U.S. Food and Drug Administration (FDA) has announced a Class I recall for this specific B. Braun Medical Inc. product, distributed across the United States. This isn't merely a suggestion to return an item; it's a serious warning that could impact the health of patients and consumers nationwide.

The Alarming Truth About a Common Medical Product

A widely used sterile solution, critical in many healthcare settings and even some homes, has a serious problem. B. Braun Medical Inc. is withdrawing specific lots of its 0.9% Sodium Chloride Injection, USP, due to the confirmed presence of particulate matter.

This isn't a cosmetic flaw; it's a hazard that can lead to severe health consequences. For U.S. consumers, especially those who use or care for someone who uses such injections, understanding this product alert is absolutely essential. Medication safety should never be compromised, and knowing if your product is affected is the first step.

What's Really Inside? The Hidden Danger

Tiny, unwanted particles could be lurking within these supposedly sterile saline solutions. The FDA's official notice specifically identifies the particulate matter as iron oxide, inorganic material, cellulose cotton fiber, or polystyrene.

Imagine introducing these foreign substances directly into a bloodstream. The agency confirmed that injecting solutions containing particulate matter can cause serious health complications, from local irritation, allergic reactions, and blood vessel blockage to more life-threatening events like pulmonary emboli or even death. This product withdrawal impacts a substantial number of units, with 201,472 containers distributed across the U.S.

Why This Isn't Just a Minor Glitch: A Class I Alert

This isn't a small issue that you can brush aside; it’s classified as a Class I alert, the most serious type the FDA issues. This classification means there's a reasonable probability that using the product will cause serious adverse health consequences or death.

What does a Class I FDA alert mean for me? It means the potential risks are severe enough to warrant immediate action. For U.S. consumers, particularly those in vulnerable populations, knowing that such a widely distributed product could pose such a danger is deeply concerning. The product was sold across the U.S., meaning patients, caregivers, and healthcare facilities nationwide could be affected by this B. Braun Medical safety notice. If you used an affected product, contacting your healthcare provider should be your immediate next step.

What You Should Do Right Now

Immediate action is required if you discover you have this specific product. Protecting yourself or your loved ones means acting quickly and decisively once you’ve identified the affected item.

Here's what you need to do:

1. Stop using the 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container immediately.
2. Carefully check your product’s label for the specific lot numbers and expiration date to confirm it is part of this alert.
3. Contact your healthcare provider or physician without delay to discuss alternative treatments and any potential health concerns.
4. Do not attempt to return the product to where you purchased it without first speaking to your healthcare provider for guidance.

Identifying the Affected Product: Don't Guess

You can't assume your injection is safe; you need to verify it. The affected product is specifically the 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, manufactured by B. Braun Medical Inc., Bethlehem, PA 18018 USA.

To determine if your product is impacted, you'll need to locate the NDC (National Drug Code), lot numbers, and expiration date on the packaging. The affected products bear the NDC 0264-1800-32, with Lot Numbers J6B435, J6B444, and J6B457, and an expiration date of 30APR2027. If you find these identifiers on your saline solution, do not use it. This safety alert was announced on September 16, 2026, rendering these products unsafe for distribution to American consumers.

This safety alert was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: Is the 0.9% Sodium Chloride Injection safe to use after a safety alert?

No, absolutely not. A Class I alert signifies a significant risk of serious harm or even death, so you must stop using the product immediately if it matches the affected lot numbers.

Q: What happens if I used an affected 0.9% Sodium Chloride Injection?

If you or someone you care for has already used an injection from the affected lots, contact your healthcare provider or physician right away to discuss potential risks and next steps.

Q: How do I know if my B. Braun saline solution is part of this alert?

You need to check the NDC (0264-1800-32), the Lot Numbers (J6B435, J6B444, J6B457), and the Expiration Date (30APR2027) on your product's packaging. These specific details identify the affected units.

Q: Can I still use the 0.9% Sodium Chloride Injection if it's under a safety alert but not expired yet?

No. Even if the product's expiration date is in the future, if it matches the affected lot numbers, it is considered unsafe due to the particulate matter and must not be used.

Q: What does a Class I FDA alert mean for me as a patient or caregiver?

A Class I alert indicates the most serious type of product withdrawal, meaning there's a strong likelihood that using the product will cause severe adverse health consequences or even death. Taking immediate action to stop use and consult a doctor is critical for your safety.