Morphine Sulfate Injection, USP, 2 Recall: Labeling: Label Mixup:

September 8, 2026 — This alert was compiled from official government recall data published by the FDA. All facts are sourced directly from official records.

Did you recently receive a prescription for Morphine Sulfate Injection, USP, 2 mg/mL, in a Simplist prefilled syringe? If so, there's a serious nationwide recall you need to know about, announced in late 2026. This isn't just a minor mix-up; it's a critical labeling error that could lead to someone receiving a completely different, much more potent medication. Nobody wants to discover their medication might be compromised, especially when it involves pain management, so let's get you all the details on this important product recall in the United States right away.

Background on Fresenius Kabi and This Medication

Fresenius Kabi USA, LLC, based in Lake Zurich, IL, is a well-known pharmaceutical company that supplies a wide range of injectable medicines used in hospitals and clinics across the country. They manufacture many crucial medications, including the Morphine Sulfate Injection that’s now under recall. These prefilled syringes are designed for ease of use by healthcare professionals for either intramuscular or intravenous administration, providing specific doses of pain relief. The Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes are prescription-only items. They are typically found in healthcare settings, meaning this recall primarily impacts hospitals, pharmacies, and clinics that administer these medications to patients, rather than direct sales to American shoppers in stores. However, if you or a loved one recently received this specific medication, understanding the issue is incredibly important for your peace of mind and safety.

The Serious Problem: What Happened?

Here is the part that really matters: the U.S. Food and Drug Administration (FDA) announced a Class I recall for a specific lot of Morphine Sulfate Injection, USP. A Class I recall is the most serious type, indicating that using or being exposed to the recalled product can cause serious health problems or even death. This particular recall stems from a critical labeling mix-up. Specifically, the "MicroVault" packaging labeled as "Morphine 2 mg/1 mL" actually contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This means the medication inside the syringe is not what the outer label says it is. According to the official notice, "MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL," which presents an undeniable hazard. This specific lot of 625,500 syringes could potentially deliver the wrong drug, posing a significant risk to patients.

Why This Matters to You (The Risk)

If you received medication from this recalled batch, the implications are very serious. Imagine being prescribed morphine for pain relief, only to receive Dilaudid (hydromorphone), a different opioid that, while also used for pain, has different potency and dosage requirements. Someone mistakenly given Dilaudid instead of Morphine could experience either an overdose if Dilaudid is administered in a higher than intended dose, or inadequate pain management if the Dilaudid dose is too low for their condition. Administering the wrong medication, especially an opioid, can lead to severe side effects such as respiratory depression (trouble breathing), low blood pressure, sedation, coma, or even death. If you or someone you know recently received a Morphine Sulfate Injection from Fresenius Kabi and experienced any unusual or adverse reactions, you need to contact your healthcare provider immediately. Tell them about this specific recall and the lot number involved. Knowing what to do if you already used a recalled product is simple: seek medical advice right away. This medication is absolutely not safe to use after a recall, especially one of this severity.

Is Your Product Affected? How to Check

Checking if your medication is part of this particular recall is straightforward, though it requires specific details. The affected product is Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes. This product recall in the United States covers units distributed nationwide. Look for the following identifiers on the packaging or syringe itself:

• Product Name: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only
• Manufacturer: Fresenius Kabi, Lake Zurich, IL
• Unit of Use NDC Number: 76045-004-01
• Unit of Sale NDC Number: 76045-004-11
• Lot Number: 6402820
• Expiration Date: 12/2028

These identifying numbers are critical for American shoppers or healthcare professionals to verify if their supply is impacted. If you find these numbers matching on any Morphine Sulfate Injection product you've received, it's part of the recall. This is how you know if your product is recalled.

What You Should Do Right Now

If you or your healthcare provider have any of the Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL Simplist prefilled syringes with the specified lot number, taking immediate action is crucial. Your safety is the top priority, so please don't delay.

1. Immediately stop using any Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL Simplist prefilled syringes identified by Lot # 6402820, Exp. Date 12/2028.
2. Contact your healthcare provider, doctor, or pharmacist right away to discuss if you or a patient may have received this recalled medication and what steps need to be taken.
3. Follow your healthcare provider’s instructions regarding the safe return or disposal of any affected medication, as proper handling of controlled substances is necessary.

Staying Safe and Informed

It can be unsettling to learn about a medication recall, especially one of this magnitude involving potential drug mix-ups. This specific product, sold across the U.S., highlights the critical importance of vigilance in healthcare. The U.S. Food and Drug Administration (FDA) works tirelessly to monitor pharmaceutical products and ensure the safety of American consumers, and they issue hundreds of such notices each year to protect public health. This agency confirmed that the risk associated with this Morphine Sulfate Injection recall is extremely high, prompting the Class I designation. Always stay informed about the medications you or your loved ones are prescribed. Don't hesitate to ask your doctor or pharmacist questions about your prescriptions, including checking lot numbers and expiration dates, especially for injectable drugs. Your proactive approach helps ensure you're getting the right treatment every time. This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: What is the specific product involved in this Fresenius Kabi recall?

A: The recall is for Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes, with Lot # 6402820 and an Expiration Date of 12/2028.

Q: Why was the Morphine Sulfate Injection recalled in 2026?

A: It was recalled due to a serious labeling mix-up where MicroVault packaging labeled as Morphine 2 mg/1 mL actually contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL, meaning the wrong drug is inside.

Q: What should I do if I think I received a recalled Morphine Sulfate Injection?

A: You should immediately stop use and contact your healthcare provider or doctor to discuss the situation and determine the appropriate next steps for your health and safe handling of the medication.

Q: Is it safe to continue using the Morphine Sulfate Injection if it’s from the recalled lot?

A: No, it is not safe to continue using the product if it matches the recalled lot number due to the risk of receiving an incorrect and potentially dangerous medication.

Q: Who issued this recall and where can I find the official notice?

A: This recall was issued by Fresenius Kabi USA, LLC, in cooperation with the U.S. Food and Drug Administration (FDA); you can find the official notice and full details at www.fda.gov.