Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up

Published: 08/05/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Dialysis Facilities,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care,
  • Office-Based Surgery,
  • Inpatient Rehabilitation Facility,
  • Pharmacy,
  • Hospice,
  • Rural Health Clinics

Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This recall is being conducted to the user level.

Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL has a reasonable probabilit…

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