Fresenius Kabi USA, LLC drug recall: Morphine Sulfate Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99533
- Recall initiated
- Aug 4, 2026
- Classified by FDA
- Aug 24, 2026
- Posted in Enforcement Report
- Aug 26, 2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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 the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 4, 2026. FDA classified it 20 days later, on Aug 24, 2026. Distribution reported by FDA: Nationwide within the USA. Fresenius Kabi USA, LLC has 67 recalls in our records.
Recalled products (1)
D-0788-2026 Class I Ongoing
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
Codes / lots: Lot #: 6402820, Exp. Date 12/2028
Quantity: 625500 syringes
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99533
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.