Drug recall D-0788-2026

Class I Ongoing reported Aug 26, 2026

Product

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

Reason for recall

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Lots and codes

Lot #: 6402820, Exp. Date 12/2028

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
625500 syringes
Distribution
Nationwide within the USA.
Type
Voluntary: Firm initiated
Recall initiated
August 4, 2026

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