Recall of Fresenius Kabi Sodium Chloride Injection

Source: FDA · United States

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Fresenius Kabi USA, LLC is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility, affecting products distributed nationwide in the US.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection, USP, because of a lack of assurance of sterility. This voluntary recall was initiated on March 11, 2026.

Which Products Are Affected

The affected products are 0.9% Sodium Chloride Injection, USP, with the following details: brand name is SODIUM CHLORIDE, manufactured by Fresenius Kabi USA, LLC. The product NDCs include 65219-466, 65219-468, 65219-470, 65219-472, and 65219-474. Specific batches affected are: 6402299, 6402300, 6402301, 6402302, 6402303 (expiration date: January 31, 2027); 6402305 and 6402398 (expiration date: February 28, 2027); 6402467 (expiration date: April 30, 2027); and 6402577, 6402578 (expiration date: June 30, 2027). The products were distributed US Nationwide, including Alaska and Puerto Rico. The recall number is D-0426-2026, and the product is for intravenous use as a human prescription drug.

What You Should Do

Consumers and healthcare providers should follow the initial firm notification, which was issued via letter, and contact Fresenius Kabi USA, LLC for further instructions regarding the recalled products. For returns or refunds, reach out to the firm at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930.

Why This Matters

This recall involves medical products essential for patient care, and the lack of assurance of sterility could potentially affect safety in healthcare settings. It highlights the importance of maintaining sterility in prescription drugs.

Source

This information is from the FDA recall database. For more details, visit the FDA website at FDA.gov and reference recall number D-0426-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Fresenius Kabi USA, LLC is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility, affecting products distributed nationwide in the US.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.