Official recall notice

FDA DrugClass INotable

Morphine Sulfate Injection USP Recall (Aug 2026) – Fresenius Kabi

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

Recall date
2026-08-05
Category
Drug
FDA class
Class I

Why it was recalled

Hazard

Due to a label mix-up

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Product description

Due to a label mix-up

Affected products

Lot #: 6402820, Exp. Date 12/2028

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