Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Recalling Firm / Manufacturer: IntegraDose Compounding Services LLC
(Minneapolis, MN, United States)
FDA Recall Number: D-0015-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
853/500 mL bags
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
October 22, 2025
Firm Initiation Date
September 16, 2025
FDA Classification Date
Oct 10, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 20250620OXY-1, Expiration date 10/18/2025
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0015-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC