Fresenius Kabi USA, LLC recalls Morphine Sulfate Injection
- Recalling company
- Fresenius Kabi USA, LLC
- 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
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Aug 4, 2026
- Reported
- Aug 26, 2026
- Distribution
- Nationwide within the USA.
- Status
- Ongoing
- Quantity
- 625500 syringes
- Lot / codes
- Lot #: 6402820, Exp. Date 12/2028
- Company location
- Lake Zurich, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0788-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0788-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.