Morphine Sulfate Injection, Solution
FDA Recall NDC 76045-004
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Morphine Sulfate (NDC 76045-004). A significant event, classified as Class I, was initiated on Aug 04, 2026 by Fresenius Kabi, Usa Llc. The reported reason for this action was: "Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Aug 04, 2026
Aug 26, 2026
625500 syringes
Recall Profile & Regulatory Data
Event ID
99533
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
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
Batch or Lot Expiration Information
Lot# : 6402820, Exp. Date 12/2028
Affected Packages Involved in this Recall
76045-004-01Product
76045-004-11Product
76045-005-01Product
76045-005-11Product
76045-006-01Product
76045-006-11Product
76045-007-01Product
76045-007-11Product
76045-008-01Product
76045-008-11Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
