Recall of Sodium Chloride Injection by Fresenius Kabi

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 specific batches of 0.9% Sodium Chloride Injection due to a 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.

Recall of Sodium Chloride Injection

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, and is classified as a Class II recall by the FDA.

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: 65219-470-05 and Unit of Sale NDC: 65219-470-30. The product NDCs involved are 65219-466, 65219-468, 65219-470, 65219-472, and 65219-474. Specific batches include Batch# 23SU10008 (Exp Date: 12/31/2026), Batch# 24JU10003 (Exp Date: 07/31/2027), Batch# 24LU10011 and 24LU10012 (Exp Date: 09/30/2027), Batch# 6402273 and 6402275 (Exp Date: 01/31/2028), Batch# 6402420 through 6402423 (Exp Date: 03/31/2028), and Batch# 6402473 through 6402476 and 6402485 (Exp Date: 04/30/2028), along with Batch# 6402516 (Exp Date: 05/31/2028). The quantity affected is not specified. These products were distributed US Nationwide, including Alaska and Puerto Rico.

What You Should Do

Consumers and healthcare providers should check their inventory for the affected batches and follow the initial firm notification, which was issued via letter. Contact Fresenius Kabi USA, LLC at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930, for information on returns or refunds related to recall number D-0427-2026.

Why This Matters

This recall addresses potential risks associated with non-sterile intravenous drugs, which could impact patient safety in medical settings. It highlights the importance of sterility in prescription medications to prevent possible health complications.

Source

FDA Recall Notice: https://www.fda.gov/recalls (Reference Recall Number D-0427-2026)

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 specific batches of 0.9% Sodium Chloride Injection due to a 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.