Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenou
Summary
The FDA issued a Class I for Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled s by Fresenius Kabi USA, LLC. Reason: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL..
Details
Source
Drug Recall
External ID
D-0788-2026
Action Date
2026-08-26
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 6402820, Exp. Date 12/2028
Quantity Affected: 625500 syringes
Reason for Recall
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Distribution
Nationwide within the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-04
Company
Lake Zurich, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 42 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 51 FDA actions in our database, including 51 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 51 FDA actions in our database, including 51 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0788-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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