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FDA-PR2026-08-04MISBRANDING

Fresenius Kabi Morphine Sulfate prefilled syringes recalled for labeling mix-up with wrong opioid

Fresenius Kabi
LABEL MIX UPNationwide distribution

Fresenius Kabi Morphine syringes recalled for wrong opioid in packaging

Fresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.

  • If you work in a healthcare facility, immediately stop using and distributing lot 6402820 (expiration 12/2028).
  • Return all units of this lot to Fresenius Kabi.
  • Contact Fresenius Kabi at 1-866-716-2459 (Monday–Friday, 8 a.m.–5 p.m. CST) if you have questions.
  • If a patient received this product, contact a physician or healthcare provider right away.

Product photos

Correct Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL lot 6402820
Correct Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL lot 6402820
Incorrect Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL seal with Dilaudid (HYDROmorphone HCl) Injection, USP Simplist® 0.5 mg/0.5 mL syringes (lot 6402813)
Incorrect Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL seal with Dilaudid (HYDROmorphone HCl) Injection, USP Simplist® 0.5 mg/0.5 mL syringes (lot 6402813)
Hazard

FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— 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 Syri

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-one-lot-morphine-sulfate-injection-usp-simplistr

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