D-0788-2026 Class I Ongoing
FDA drug recall D-0788-2026 was initiated by Fresenius Kabi USA, LLC on August 4, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 625500 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- August 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 625500 syringes
Product Description
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.
Distribution Pattern
Nationwide within the USA.
Code Information
Lot #: 6402820, Exp. Date 12/2028