FDA Drug · D-0788-2026

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

Class I · Ongoing

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

Affected lots / codes — check yours against thisLot #: 6402820, Exp. Date 12/2028

Recalling firm: Fresenius Kabi USA, LLC, Lake Zurich, IL
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 625500 syringes
Distribution: Nationwide within the USA.
Recall initiated: August 4, 2026
Classified: August 24, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0788-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →