Morphine Sulfate Injection Recall: What To Do

fresenius kabi recall notices reached hospitals and pharmacies across the country in late August 2026. The U.S. Food and Drug Administration classified the action as Class I. That is the agency’s most serious category. The recalled product is Morphine Sulfate Injection, USP, 2 mg/mL, sold in Simplist prefilled syringes. The problem is a label mixup. Some MicroVault packages labeled as morphine actually contain a prefilled syringe of Dilaudid. For patients receiving injectable pain medication, that difference matters a great deal.

What the Fresenius Kabi Recall Covers

The recalled item is Morphine Sulfate Injection, USP, 2 mg/mL, in 1 mL single-dose Simplist prefilled syringes. The labeling states “For Intramuscular or Intravenous use, Rx only.” The manufacturer is Fresenius Kabi USA, LLC, of Lake Zurich, Illinois. The Unit of Use NDC number is 76045-004-01. The Unit of Sale NDC number is 76045-004-11.

The FDA assigned this action recall number D-0788-2026. The recall date on the agency record is August 26, 2026. The scope covers 625,500 units. That is a large distribution footprint for an injectable opioid. As a result, the fresenius kabi recall touches many hospitals, surgical centers, and long-term care facilities.

This is a prescription hospital product, not a retail item. In most cases, consumers never handle these syringes directly. Pharmacy departments, anesthesia providers, and nursing staff do. However, patients and families still have reason to pay attention. Knowing what was administered during a hospital stay is part of understanding your own medical record.

The agency record does not list retail outlets or consumer sales channels. Distribution for products like this typically runs through wholesalers and institutional pharmacy accounts. For example, a hospital pharmacy would receive cases and stock automated dispensing cabinets. That is where a mislabeled MicroVault package could go unnoticed until the moment of use.

The Hazard and Reported Injuries

The hazard in this fresenius kabi recall is a labeling error. Specifically, the FDA describes a label mixup. A MicroVault labeled as Morphine 2 mg/1 mL contains a prefilled syringe of Dilaudid 0.5 mg/0.5 mL. Dilaudid is a brand name for hydromorphone. It is a different opioid with different potency.

That distinction is the core safety concern. Clinicians dose morphine and hydromorphone differently. A syringe grabbed as morphine but containing hydromorphone can lead to a dosing error. Opioid dosing errors can cause excessive sedation and slowed breathing. However, the outcome in any specific case depends on the patient, the route, and the monitoring in place.

The FDA record does not state whether injuries have been reported in connection with this recall. That silence cuts both ways. It does not mean harm occurred. It also does not mean no harm occurred. This guide will not claim either. Readers should rely on the official notice and their own medical records rather than assumptions.

Class I is the FDA’s highest severity tier. The agency reserves it for situations where use of the product could cause serious adverse health consequences or death. That classification reflects potential risk, not a finding that anyone was hurt. Typically, an opioid mislabeling issue draws that tier because the margin for error is narrow.

What To Do If You Own This Product

Stop using the affected product. That is the first step in any Class I drug recall. If you are a pharmacist, quarantine remaining stock immediately. If you manage an automated dispensing cabinet, pull the item from active inventory. Do not rely on the outer label alone to confirm contents.

To identify the product, check the NDC numbers against your inventory records. Look for 76045-004-01 on the unit of use and 76045-004-11 on the unit of sale. Confirm the manufacturer is Fresenius Kabi USA, LLC, Lake Zurich, IL. Because this fresenius kabi recall involves a mixup inside the package, visual inspection of the syringe itself matters.

For the remedy, follow the instructions in the official notice linked on this page. We are not stating the remedy here. The agency record for this recall contains remedy text that does not match the product. As a result, the safest course is to use the manufacturer’s and FDA’s own instructions rather than a secondhand summary.

Patients and families have a narrower role. You cannot return hospital stock yourself. However, you can ask your care team whether the affected lot was used during your treatment. You can also request your medication administration record. If you believe you experienced an adverse event, report it to the FDA’s MedWatch program and tell your physician.

Does a Fresenius Kabi Recall Mean You Can Sue?

No. A recall is a safety action, not a lawsuit. That point deserves plain language. The FDA classifies recalls to protect the public and remove risk from the supply chain. A recall notice does not create a legal claim, and it does not name any defendant. It is a regulatory event.

A legal claim generally requires more. In most cases, you need an actual injury. You also need evidence that the defective product caused that injury. Lawyers call that causation. Without both pieces, a fresenius kabi recall by itself is not a case. That is true no matter how serious the classification.

We are not aware of verified litigation over this specific fresenius kabi recall. This guide does not claim any lawsuit exists. It also does not promise compensation to anyone. If you were harmed, you may be eligible to pursue a claim. Whether that is true in your situation is a question for a licensed attorney.

If you are considering legal advice, gather documentation first. Collect discharge paperwork, medication records, and any notes about adverse reactions. Note dates and facility names. Then consult an attorney licensed in your state who handles pharmaceutical injury matters. Many offer free consultations, and deadlines called statutes of limitations vary by state.

How Recalls Connect to Mass Tort Cases

Recalls and mass torts are separate things, but they often intersect. A recall notice is a dated, official record. It documents what the company knew and when it acted. For example, in the Philips CPAP litigation, the 2021 recall of certain sleep apnea devices became a central reference point for thousands of consolidated claims. The recall did not create the cases. It supplied evidence.

The Takata airbag recalls followed a similar pattern. Those recalls grew to cover tens of millions of vehicles. Plaintiffs later used recall timelines and manufacturer communications as part of their proof. However, individual outcomes still turned on individual facts. Some claimants recovered, and others did not. That is the honest picture, and it applies equally here.

Frequently Asked Questions

Is this fresenius kabi recall a consumer product recall?

No. The recalled item is a prescription injectable used in clinical settings. It is dispensed by pharmacies and administered by healthcare providers. Consumers generally do not purchase or store it at home.

Were any injuries reported in this fresenius kabi recall?

The FDA record does not state whether injuries have been reported. Because of that, we are not claiming injuries occurred or did not occur. Check the official notice for any updates the agency posts later.

How do I return the recalled product?

Follow the instructions in the official FDA notice linked on this page. The remedy details in the agency record did not match this product, so we are not summarizing them. Your pharmacy or the manufacturer can confirm the correct process.

Does a Class I classification mean the product is dangerous to everyone?

Class I means the FDA believes use could cause serious harm or death. It reflects potential risk across the recalled population. It is not a finding about any one patient’s outcome.

Should I stop taking prescribed pain medication because of this fresenius kabi recall?

Do not stop prescribed treatment on your own. Talk to your prescriber first. Abruptly discontinuing opioid therapy can carry its own risks, and your provider can identify a safe alternative.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

• U.S. Food and Drug Administration: official recall database — the record of truth for this notice
• CPSC: cpsc.gov — household goods, toys, furniture, appliances
• FDA: fda.gov — food, drugs, and medical devices
• NHTSA: nhtsa.gov — vehicles, tires, and child car seats
• USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed September 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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• Tort Reform by State — 50-State Comparison

Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.