Fresenius Kabi Morphine Sulfate prefilled syringes recalled for labeling mix-up with wrong opioid
Fresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- If you work in a healthcare facility, immediately stop using and distributing lot 6402820 (expiration 12/2028).
- Return all units of this lot to Fresenius Kabi.
- Contact Fresenius Kabi at 1-866-716-2459 (Monday–Friday, 8 a.m.–5 p.m. CST) if you have questions.
- If a patient received this product, contact a physician or healthcare provider right away.
Is yours affected?
Compare your label or packaging with the recalled product.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Photos from the FDA
Details
- Illnesses reported
- None reported
In the FDA's words
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.
Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Read the full announcementShow less
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
Product was distributed nationwide to distributors and wholesalers.
Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.
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 have 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com .
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online : www.fda.gov/medwatch/report.htm
Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
For return kits and 222 forms please contact Inmar Rx Solutions at 1-855-860-7311, from 9 a.m. to 5 p.m. Eastern Standard Time.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.
Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that ad
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