Morphine Sulfate Injection, USP, 2 mg /mL
Recalled by Fresenius Kabi USA, LLC
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
Fresenius Kabi USA, LLC has recalled Morphine Sulfate Injection, USP, 2 mg /mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on August 26, 2026 and was initiated on August 4, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Morphine Sulfate Injection, USP, 2 mg /mL, with approximately 625500 syringes affected. The company behind the recall is Fresenius Kabi USA, LLC, based in Lake Zurich, IL. The FDA describes the product as: “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”
Why was Morphine Sulfate Injection, USP, 2 mg /mL recalled?
According to the FDA, the stated reason for the recall is: “Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.”
What should you do?
If you think you may have bought Morphine Sulfate Injection, USP, 2 mg /mL, compare it against the product description and identifying codes (Lot #: 6402820, Exp. Date 12/2028) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Fresenius Kabi USA, LLC or your local health authority.
About this recall
This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Morphine Sulfate Injection, USP, 2 mg /mL. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide within the USA..
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot #: 6402820, Exp. Date 12/2028
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- August 26, 2026
- Recall started
- August 4, 2026
- Distributed in
- IL
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Morphine Sulfate Injection, USP, 2 mg /mL recalled?+
According to the FDA: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of…
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have Morphine Sulfate Injection, USP, 2 mg /mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0788-2026. Information last synced from the FDA on September 7, 2026.
