---
title: "Fresenius Kabi: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL — FDA announcement Aug 5, 2026 | Is It on Recall"
description: "Due to a label mix-up"
url: https://isitonrecall.com/recall/fdapress-5b292dd0c8c4fbde-fresenius-kabi-morphine-sulfate-injection-usp-simplist-r-2-mg-1-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-one-lot-morphine-sulfate-injection-usp-simplistr)

## 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 |

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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-one-lot-morphine-sulfate-injection-usp-simplistr).

## 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.

## What to do next

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-one-lot-morphine-sulfate-injection-usp-simplistr)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Fresenius Kabi records](https://isitonrecall.com/brand/fresenius-kabi/)