Class IDrug
Morphine Sulfate Injection recall
Summary
Fresenius Kabi USA, LLC is recalling Morphine Sulfate Injection (drug). According to the FDA report, the reason is: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
Fresenius Kabi is recalling Morphine Sulfate Injection 2 mg/mL Simplist prefilled syringes because a package labeled as morphine 2 mg/1 mL was found to contain a Dilaudid (hydromorphone) 0.5 mg/0.5 mL syringe.
Why it matters
When a package or syringe contains a different drug or strength than the label says, a patient can receive the wrong medicine or the wrong dose. With potent medicines, such as opioids, that kind of error can be dangerous. Hydromorphone (Dilaudid) is a more potent opioid than morphine, so a mix-up can mean a patient receives a much stronger dose than intended.
Who should pay attention
Hospital, surgical and pharmacy staff who stock Simplist morphine syringes.
Distribution in the FDA report: Nationwide within the USA.
How to check your product
Check the lot number and expiration date on the package, and check that the syringe matches its label before use.
Codes listed by the FDA: Lot #: 6402820, Exp. Date 12/2028
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- Product
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
- Reason
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Lot / code info
- Lot #: 6402820, Exp. Date 12/2028
- Quantity
- 625500 syringes
- Distribution
- Nationwide within the USA.
- Recalling company
- Fresenius Kabi USA, LLC, Lake Zurich, IL United States
- Recall started
- August 4, 2026
- FDA report date
- August 26, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0788-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Fresenius Kabi USA, LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.