FDA Drug recall D-0788-2026
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
- FDA Drug
- Class I
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class I recall of Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre… by Fresenius Kabi Usa, citing labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0788-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-04 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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.
Identifiers
| ndc | 76045-004-01 |
|---|---|
| ndc | 76045-004-11 |
| ndc | 76045-005-01 |
| ndc | 76045-005-11 |
| ndc | 76045-006-01 |
| ndc | 76045-006-11 |
| ndc | 76045-007-01 |
| ndc | 76045-007-11 |
| ndc | 76045-008-01 |
| ndc | 76045-008-11 |
| code_info | Lot #: 6402820, Exp. Date 12/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0788-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.