Compounded oxytocin bags recalled after testing found no oxytocin present
IntegraDose Compounding Services is recalling 853 bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride after testing revealed there was no oxytocin in the IV bag.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, from IntegraDose Compounding Services of Minneapolis, Minnesota, is being recalled as a subpotent drug. Testing revealed there was no oxytocin in the IV bag.
The recall covers 853 500 mL bags from lot 20250620OXY-1, expiring 18 October 2025, carrying NDC 71139-0012-1. The product was distributed nationwide in the United States. The FDA has classified the recall as Class I.
Oxytocin is given intravenously in obstetric care, so a bag containing none of the drug would deliver no treatment at all while appearing to be in use.
Facilities holding the affected lot should quarantine it immediately and follow the firm's instructions.
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 — Injectable
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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