Recall of Fresenius Kabi 5% Dextrose Injection Due to Sterility Concerns
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (972 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.