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FDA recall, , High risk

Fresenius Kabi Morphine Sulfate Injection

Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Summary by Recall Canary from the FDA notice

What happened

Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, began a recall of Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes on August 4, 2026, due to a label mix-up. The syringes, labeled as Morphine 2 mg/1 mL, contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. The recall was added to the FDA's Enforcement Report on August 17, 2026, and classified by the FDA on August 24, 2026.

The product was distributed nationwide within the USA. The recall affects 625500 syringes.

More labeling error recalls

What to do

If a code on your package is listed below:

  1. 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.
  2. Contact your physician or health care provider if you have experienced any problems that may be related to receiving this drug product.
  3. Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.
  4. 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.

Is yours affected?

Match the lot code and NDC listed under your product.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. Morphine Sulfate Injection, USP

    Strength
    2 mg
    Lot code
    • 6402820
    Recall number
    D-0788-2026
  2. NDC
    • 76045-004-01
    • 76045-004-11
    Lot code
    • 6402820

Recall details

Company began the recall
Sold in

Nationwide within the USA.

Company
Fresenius Kabi USA, LLCLake Zurich, Illinois
Hazard
Labeling error
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99533
Recall number
D-0788-2026
Quantity recalled
625500 syringes

All recalls from Fresenius Kabi USA, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. Classified by FDA

  5. In FDA's weekly enforcement report

  6. Summary updated

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Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)