FDA Recall of Fresenius Kabi Dextrose Injection
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Fresenius Kabi USA, LLC is voluntarily recalling batches of 5% Dextrose 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.
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What Happened
Fresenius Kabi USA, LLC initiated a voluntary recall of specific batches of 5% Dextrose Injection, USP because of a lack of assurance of sterility, which could potentially compromise product safety. This recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) in a 250 mL freeflex bag. The specific NDC numbers are Unit of Use: 65219-458-05 and Unit of Sale: 65219-458-30. Additional related NDC codes from the product include 65219-456, 65219-464, 65219-458, 65219-460, and 65219-462. The affected batch is 6402165 with an expiration date of 05/30/2028. The recall involves products distributed US Nationwide, including Alaska and Puerto Rico, though exact quantities are not specified.
What You Should Do
Consumers and healthcare providers who have the affected products should follow the initial firm notification, which was issued via letter, and contact Fresenius Kabi USA, LLC for instructions on returns or refunds. The recalling firm is located at 3 Corporate Dr, Lake Zurich, IL 60047-8930.
Why This Matters
This recall highlights potential risks in medical product sterility, which could affect patient safety in healthcare settings across the United States. It underscores the importance of ensuring proper manufacturing standards for prescription drugs.
Source
This information is from the FDA recall notice, recall number D-0437-2026. For more details, refer to the FDA website.
Original source: FDA Official Notice ↗
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