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Class I · Most seriousActive recall

Morphine Sulfate

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: 6402820, Exp. Date 12/2028
Where it was soldNationwide within the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi, USA LLC
Brand nameMORPHINE SULFATE
Generic nameMORPHINE SULFATE
Active ingredient(s)MORPHINE SULFATE
Distributed by / forFresenius Kabi USA, LLC
Show the full FDA record
Full product labelMorphine 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
Recalling firmFresenius Kabi USA, LLC
DistributionNationwide within the USA.
Quantity625500 syringes
Recall initiated2026-08-04
Report date2026-08-26
Recall completed—
Recall numberD-0788-2026
ClassificationClass I
FDA statusOngoing
Origin on fileLake Zurich IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.