FDAFDA · Food and drugs·Recall number D-0788-2026
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
Published August 26, 2026 · Recall initiated: August 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- MORPHINE SULFATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide within the USA.
- Lot
- Lot #: 6402820, Exp. Date 12/2028
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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