FDAFDA recall D-0788-2026 · Aug 26, 2026
Fresenius Kabi USA, LLC: Morphine Sulfate Injection recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 6402820, Exp. Date 12/2028
- Quantity
- 625500 syringes
- Distribution
- Nationwide within the USA.
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-04
Source: openFDA enforcement record D-0788-2026 · search recall number D-0788-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.