FDA Drugs recall ·
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0788-2026
- Date
- (initiated August 4, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 625500 syringes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 6402820, Exp. Date 12/2028
Distribution
Nationwide within the USA.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0788-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.