Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL

  • Due to a label mix-up
  • Company: Fresenius Kabi
  • Drugs
  • FDA
  • August 4, 2026

Product details

  • Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL

Company announcement

Fresenius Kabi is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL nationwide.

The recall is due to a label mix-up where a MicroVault labeled as Morphine 2 mg/1 mL may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

No adverse event reports, injuries, or deaths have been reported to date for this lot number.

Risk:

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 probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants.

Impacted states: Nationwide

Products:

- Morphine Sulfate Injection USP, Simplist® 2 mg / 1 mL, 1 mL fill in a single dose 1 mL Simplist® prefilled syringe (UPC code(s): 7604500401)

Contact

For more information, call 1-800-551-7176 or email productcomplaint.USA@fresenius-kabi.com.

View the original FDA notice

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