Oxytocin IV Bags Recalled for Missing Active Ingredient
IntegraDose is recalling 853 intravenous Oxytocin bags because testing revealed they contain no active oxytocin. Patients receiving these bags would not get the intended medication.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification mandates Critical (5) rating. The product is subpotent (contains no active ingredient), representing a critical medication error with a prescription intravenous drug.
Plain-English summary
IntegraDose Compounding Services LLC is recalling 853 bags of Oxytocin 30 Units/500 mL intravenous solution (Lot 20250620OXY-1, expiration date 10/18/2025). Testing revealed that the IV bags contain no active oxytocin—only saline solution.
This is a Class I recall due to subpotency (missing active ingredient). Oxytocin is a prescription intravenous medication. Patients who received these bags did not receive the intended medication.
The affected product was distributed nationwide in the United States. The manufacturer is IntegraDose Compounding Services LLC, located in Minneapolis, Minnesota.
Healthcare providers should immediately quarantine any remaining bags from Lot 20250620OXY-1. Patients should consult their healthcare provider if they believe they received this product.
The recalled product
- Product
- Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug
- Hazard
- subpotent-drug
- medication-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 20250620OXY-1
- Expiration date 10/18/2025
Distribution
Distributed nationwide across the United States.
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