Recall of Fresenius Kabi 0.9% Sodium Chloride Injection

Source: FDA · United States

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Fresenius Kabi USA, LLC is voluntarily 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.

Recall Article

What Happened

Fresenius Kabi USA, LLC is initiating a voluntary recall of certain batches of 0.9% Sodium Chloride Injection because of a lack of assurance of sterility.

Which Products Are Affected

The affected product is 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) in a 1,000 mL Single Dose freeflex bag. The NDC numbers are Unit of Use: 65219-282-01 and Unit of Sale: 65219-282-10. Specific batches include: 23SU10001 with expiration date 12/31/2026; 24AU10003, 24AU10004, 24AU10005, and 24AU10008 with expiration date 01/31/2027; 24EU10001 and 24EU10002 with expiration date 05/31/2027; 24PU10002 with expiration date 11/30/2027; 25BU10003 with expiration date 02/29/2028; and 25EU10005 with expiration date 05/31/2028. This recall involves products distributed US Nationwide, including Alaska and Puerto Rico.

What You Should Do

Consumers and healthcare providers should check if they have any of the affected batches and contact Fresenius Kabi USA, LLC for instructions, as the recall was initiated via letter.

Why This Matters

This recall underscores the need for sterility in prescription drugs to ensure patient safety, potentially impacting medical treatments across the affected regions.

Source

FDA Recall Number: D-0433-2026. For more information, refer to the FDA website.

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 voluntarily 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.