HIGH

IntegraDose Oxytocin IV Solution Recall 2025 for Subpotent Drug, 853 Bags Nationwide

IntegraDose Compounding Services recalled 853 IV bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride. The recall is nationwide in the United States. Testing found no oxytocin in the IV bags. Stop using the product and contact IntegraDose or a healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
September 16, 2025
Hazard Level
HIGH
Brand
IntegraDose Compounding Services
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
PREGNANT, GENERAL

Hazard Information

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact IntegraDose Compounding Services LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Oxytocin solutions are used in obstetric care to induce or augment labor and to manage postpartum bleeding. This product was produced by a compounding service and distributed nationwide.

Why This Is Dangerous

A subpotent drug means the bag contains insufficient oxytocin to perform its intended therapeutic effect.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Healthcare facilities may need to switch to alternative oxytocin products and may experience workflow disruptions. No injuries have been reported yet.

Practical Guidance

How to identify if yours is affected

  1. Verify NDC 71139-0012-1 on the product label
  2. Check Lot number 20250620OXY-1
  3. Check expiration date 10/18/2025
  4. Confirm packaging indicates Oxytocin 30 Units/500 mL in 0.9% NaCl

Where to find product info

Recall details are posted on the FDA enforcement page for D-0015-2026. Look for the lot and expiration identifiers on each bag.

What timeline to expect

Replacement or disposition typically follows recall processing timelines; 4-8 weeks is a common industry window.

If the manufacturer is unresponsive

  • Document all outreach attempts
  • Escalate to FDA MedWatch with recall details
  • Consult state board of pharmacy or hospital risk management if needed

How to prevent similar issues

  • Source compounded oxytocin only from licensed providers with GMP practices
  • Verify lot number and expiration on every bag
  • Maintain a recall tracking log and verify supplier recalls before use
  • Require confirmation of potency for critical preparations before administration

Documentation advice

Keep the recall notification letter, product labels, lot numbers, and all correspondence with the supplier and health facility.

Product Details

Product: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only Brand: IntegraDose Compounding Services LLC NDC: 71139-0012-1 Lot: 20250620OXY-1 Expiration: 10/18/2025 Quantity: 853 bags Sold/Distributed: Nationwide in the USA Recall Date: 2025-09-16 Status: ACTIVE

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 853 bags recalled
  • NDC 71139-0012-1
  • Lot 20250620OXY-1
  • Expiration 10/18/2025
  • Distribution nationwide in the USA
  • Class I recall (high hazard)

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
PREGNANTGENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #: 20250620OXY-1
Expiration date 10/18/2025
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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