FDA Drug Recall Alert – Morphine Sulfate Injection USP, Simplist 2 mg per 1 mL
| Date: | August 20, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Drug Recall Alert – Morphine Sulfate Injection USP, Simplist 2 mg per 1 mL |
| Business: | Medi-Cal Managed Care/Medicare Advantage D-SNP |
On August 05, 2026, the Food and Drug Administration (FDA) released a recall announcement for One Lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-one-lot-morphine-sulfate-injection-usp-simplistr?utm_medium=email&utm_source=govdelivery#recall-announcement
Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up
Company Announcement
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.
Affected Products
Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe was distributed nationwide in the United States with a first ship date of January 29, 2026, and last ship date of 06/09/2026. NDC, lot, and expiration date can be found on the table.
| Product Name / Strength | Dosage Form / Package | NDC | Lot Number | Expiration Date |
| Morphine Sulfate Injection USP, Simplist | 2mg/1mL, 1mL fill in a single dose 1mL
Simplist® prefilled syringe |
76045-
0004-01, 76045- 0004-11 |
6402820 | 12/2028 |
What to Do
If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that has been shipped or may have been shipped, the product involved in this recall.
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.
Contact Information
| Consumers:
Fresenius Kabi Medical Affairs or Vigilance Departments 1-800-551-7176 |
Media: Matt Kuhn
1-847-220-3033 |
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
