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
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Agency
- FDA Drug
- Recall date
- Aug 4, 2026
- Status
- Ongoing
- Company
- Fresenius Kabi USA, LLC
1. What product was recalled?
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
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
Quantity: 625500 syringes
Code or lot text: Lot #: 6402820, Exp. Date 12/2028
- LOT
- Exp. Date 12/2028
- LOT
- Lot #: 6402820
- NDC
- 76045-004
- NDC
- 76045-004-01
- NDC
- 76045-004-11
- NDC
- 76045-005
- NDC
- 76045-005-01
- NDC
- 76045-005-11
- NDC
- 76045-006
- NDC
- 76045-006-01
- NDC
- 76045-006-11
- NDC
- 76045-007
- NDC
- 76045-007-01
- NDC
- 76045-007-11
- NDC
- 76045-008
- NDC
- 76045-008-01
- NDC
- 76045-008-11
- NDC
- 76045-238
- NDC
- 76045-238-01
- NDC
- 76045-238-10
- RECALL-NUMBER
- D-0788-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- updated
- updated
- created
10. Where is the official source?
Open the official FDA Drug source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.