Recall of Dextrose Injection by Fresenius Kabi USA
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Fresenius Kabi USA, LLC is recalling specific batches of 5% Dextrose Injection due to lack of assurance of sterility, affecting products distributed nationwide in the US.
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 is initiating a voluntary recall of certain batches of 5% Dextrose Injection, USP because of a lack of assurance of sterility, as classified by the FDA as a Class II recall.
Which Products Are Affected
The affected products include 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) in 100 mL freeflex bags. The product NDCs are 65219-456, 65219-464, 65219-458, 65219-460, and 65219-462. Specific package NDCs 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 affected batches are 6402399, 6402400, and 6402401, with an expiration date of February 28, 2027. These products were distributed nationwide in the United States, including Alaska and Puerto Rico. The quantity affected is not specified.
What You Should Do
Consumers and healthcare providers who have the affected products should check their inventory for the specified batches and NDCs and contact Fresenius Kabi USA, LLC for further instructions, as the recall was initiated via letter. The firm's address is 3 Corporate Dr, Lake Zurich, IL 60047-8930. The official recall number is D-0436-2026.
Why This Matters
This recall addresses potential risks associated with non-sterile intravenous drugs, which could affect patient safety in medical settings. It underscores the importance of sterility in prescription medications to prevent possible health complications.
Source
Attributed to the FDA, recall number D-0436-2026.
Original source: FDA Official Notice ↗
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