Fresenius Kabi Morphine Sulfate Injection Recall
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Fresenius Kabi USA is recalling 625,500 syringes of Morphine Sulfate Injection due to a label mixup with Dilaudid.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 7, 2026 and geographically references United States. Its severity classification of "high" 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, fda, Drugs.
What Happened
Fresenius Kabi USA, LLC initiated a voluntary recall of Morphine Sulfate Injection due to labeling mixup. A MicroVault labeled as Morphine 2 mg/1 mL contains a prefilled syringe of Dilaudid 0.5 mg/0.5 mL.
Which Products Are Affected
Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes for intramuscular or intravenous use. Unit of Use NDC: 76045-004-01; Unit of Sale NDC: 76045-004-11. Lot #: 6402820, Exp. Date 12/2028. Quantity: 625,500 syringes. Distributed nationwide in the United States. Recall number: D-0788-2026. Classification: Class I.
What You Should Do
Consumers and healthcare providers should check product labeling and lot information against the recall details.
Why This Matters
The mislabeling could result in administration of the wrong medication, posing a serious health risk.
Source
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (FDA recall event ID 99533, report date 20260826)
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 (990 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.