FDA-Drug2026-08-26Class IMISBRANDING
Fresenius Kabi morphine injection recalled for label mixup with wrong drug inside
What this means
Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.
- Check your morphine sulfate injection for lot number 6402820 (exp. 12/2028).
- Do not use if the label says Morphine 2 mg/mL but the syringe looks different or unexpected.
- Contact your pharmacy or healthcare provider immediately if you have this lot.
- Return unused syringes to your pharmacy or healthcare facility.
The agency's original wording
Hazard
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the USA.
Affected count
625500 syringes
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2026More Fresenius Kabi recalls
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- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
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