Morphine Sulfate Injection recall
FDA recall D-0788-2026 · initiated Aug 4, 2026
Fresenius Kabi USA, LLC recalled Morphine Sulfate Injection in Aug 2026 — an FDA Class I recall (D-0788-2026) because Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 625500 syringes
Details
- Product
- 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
- Recalling company
- Fresenius Kabi USA LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA.
- Initiated
- Aug 4, 2026
- FDA report date
- Aug 26, 2026
Frequently asked
- Was Morphine Sulfate Injection recalled?
- Fresenius Kabi USA, LLC recalled Morphine Sulfate Injection in Aug 2026 — an FDA Class I recall (D-0788-2026) because Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Morphine Sulfate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0788-2026 was: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Is a recalled Morphine Sulfate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Morphine Sulfate Injection are affected?
- Distributed: Nationwide within the USA.. The recall covers these lots — Lot #: 6402820, Exp. Date 12/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0788-2026.