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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- IntegraDose Compounding Services
- Product type
- IV Oxytocin Solution
- Model numbers
- Lot #: 20250620OXY-1, Expiration date 10/18/2025
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 16, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify NDC 71139-0012-1 on the product label
- Check Lot number 20250620OXY-1
- Check expiration date 10/18/2025
- 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.
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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
- Distribution nationwide in the USA
- Class I recall (high hazard)
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Safety Guide
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