Morphine Sulfate Injection — Class I drug recall D-0788-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-08-26, distributed nationwide. Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5
| Recall number | D-0788-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-08-04 |
| Classified | 2026-08-24 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 625,500 syringes |
| Reason classes | labeling |
| NDC | 76045-0004, 76045-0004-01, 76045-0004-11, 76045-0005, 76045-0005-01, 76045-0005-11, 76045-0006, 76045-0006-01, 76045-0006-11, 76045-0007, 76045-0007-01, 76045-0007-11, 76045-0008, 76045-0008-01, 76045-0008-11, 76045-0238, 76045-0238-01, 76045-0238-10 |
| Lot numbers | 6402820 |
| Expiration dates | 2028-12 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0788-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.