Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Morphine Sulfate Injection
Class I — High risk. Reasonable probability of 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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDCs
76045-0004-01
76045-0004-11
Compare with the code on your package — it is the most precise check available.
Drug: Morphine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Morphine Sulfate NDC 76045-0004 |
2 mg/mL | Injection, Solution Intramuscular|intravenous |
Fresenius Kabi, USA LLC | Rx · CII |
- Recalling firm
- Fresenius Kabi USA, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Aug 4, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0788-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Morphine recalls
See all
Class II · Moderate risk
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 15 mg
Failed Impurities/Degradation Specification
Other recalls by Fresenius Kabi USA, LLC
All 2026 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
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