Recall archive / FDA company announcement

Fresenius Kabi: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL — FDA announcement Aug 5, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 5, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
Reason: Due to a label mix-up
Classification: Not supplied
Recalling firm: Fresenius Kabi
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 5b292dd0c8c4fbde

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This recall is being conducted to the user level.; Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants. To date, no adverse event reports have been received for this lot number.; Product Name/Product Size \| Unit of Use NDC Number \| Unit of Sale NDC Number \| Product Code \| Lot Number \| Expiration Date \| First Ship Date \| Last Ship Date; Morphine Sulfate Injection USP, Simplist® 2 mg / 1 mL, 1 mL fill in a single dose 1 mL Simplist® prefilled syringe \| 76045- 004-01 \| 76045- 004-11 \| 764411 \| 6402820 \| 12/2028 \| 01/29/2026 \| 06/09/2026

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This recall is being conducted to the user level.; Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants. To date, no adverse event reports have been received for this lot number.; Product Name/Product Size | Unit of Use NDC Number | Unit of Sale NDC Number | Product Code | Lot Number | Expiration Date | First Ship Date | Last Ship Date; Morphine Sulfate Injection USP, Simplist® 2 mg / 1 mL, 1 mL fill in a single dose 1 mL Simplist® prefilled syringe | 76045- 004-01 | 76045- 004-11 | 764411 | 6402820 | 12/2028 | 01/29/2026 | 06/09/2026

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product Name/Product Size	Unit of Use NDC Number	Unit of Sale NDC Number	Product Code	Lot Number	Expiration Date	First Ship Date	Last Ship Date
Morphine Sulfate Injection USP, Simplist® 2 mg / 1 mL, 1 mL fill in a single dose 1 mL Simplist® prefilled syringe	76045- 004-01	76045- 004-11	764411	6402820	12/2028	01/29/2026	06/09/2026

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Aug 5, 2026
Company announcement date: Aug 4, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.