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

Published: 08/11/2026

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,
  • Ambulatory Care,
  • Office-Based Surgery,
  • 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. .

  • Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Fresenius Kabi is notifying its distributo…

Sign Up for Free Trial