FDA Recall of Fresenius Kabi's Sodium Chloride Injection

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

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

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, fda, 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 specific batches of 0.9% Sodium Chloride Injection, USP, because of a lack of assurance of sterility, as announced in a voluntary firm-initiated recall.

Which Products Are Affected

The affected products include 0.9% Sodium Chloride Injection, USP, in various sizes with the following details: Unit of Use NDC 65219-472-05 and Unit of Sale NDC 65219-472-20, among others like 65219-466-05, 65219-466-60, 65219-468-05, 65219-468-50, 65219-470-05, 65219-470-30, 65219-472-05, 65219-472-20, 65219-474-05, and 65219-474-10. The batches involved are 24LU10013, 24LU10014 with expiration date 09/30/2027, and 24NU10001, 24NU10002 with expiration date 10/31/2027. The recall affects an unknown quantity of units distributed to US Nationwide, Alaska, and Puerto Rico.

What You Should Do

Consumers who have the affected products should check for the specified batches and NDCs and follow the initial firm notification via letter for further instructions on returns or refunds. Contact Fresenius Kabi USA, LLC at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930.

Why This Matters

This recall addresses potential risks associated with non-sterile medical products, emphasizing the importance of sterility in intravenous drugs to ensure patient safety and prevent possible health issues.

Source

FDA recall notice D-0428-2026, attributed to the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection due to lack of assurance of sterility, affecting products distributed nationwide.
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.