Morphine Sulfate Injection recall
Fresenius Kabi USA, LLC recalled Morphine Sulfate Injection on August 26, 2026 because of labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. It was sold nationwide.
Why it was recalled
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
What's recalled
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
Quantity: 625500 syringes
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- Nationwide
Nationwide within the USA. - Status
- Ongoing
- Recall number
- D-0788-2026
- Source
- U.S. Food and Drug Administration
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