Recall of Fresenius Kabi 5% Dextrose Injection Due to Sterility Concerns

Source: FDA · United States

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Fresenius Kabi USA, LLC is voluntarily recalling certain batches of 5% Dextrose Injection because of a lack of assurance of sterility, affecting products distributed nationwide in the United States.

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.

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Recall Article

What Happened

Fresenius Kabi USA, LLC is voluntarily recalling batches of 5% Dextrose Injection due to a lack of assurance of sterility.

Which Products Are Affected

The affected product is 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) in a 100 mL freeflex bag. NDC numbers include 65219-456-05, 65219-456-60, 65219-464-05, 65219-464-50, 65219-458-05, 65219-458-30, 65219-460-05, 65219-460-20, 65219-462-05, and 65219-462-10. The batch number is 6402296 with an expiration date of 07/31/2026. Distribution occurred nationwide in the United States, including Alaska and Puerto Rico.

What You Should Do

Consumers should follow the instructions in the initial firm notification letter from Fresenius Kabi USA, LLC.

Why This Matters

This recall involves a human prescription drug used intravenously, which could impact patient safety due to potential sterility issues.

Source

Information from the FDA: Recall Number D-0435-2026.

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 voluntarily recalling certain batches of 5% Dextrose Injection because of a lack of assurance of sterility, affecting products distributed nationwide in the United States.
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.