HIGH

IntegraDose Recalls Oxytocin Injection Due to No Active Ingredient

IntegraDose Compounding Services LLC recalled 853 bags of Oxytocin 30 Units/500 mL on September 16, 2025. Testing revealed these IV bags contain no oxytocin, posing serious health risks. The recall affects products distributed nationwide in the USA.

Quick Facts at a Glance

Recall Date
September 16, 2025
Hazard Level
HIGH
Brand
IntegraDose Compounding Services
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
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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Product Details

The recalled product is Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use. Lot number is 20250620OXY-1 with an expiration date of October 18, 2025. The product was distributed nationwide.

The Hazard

Testing revealed that the recalled IV bags contain no oxytocin, rendering them ineffective for use in medical settings. This poses a high health risk, especially in situations where oxytocin is critical for labor induction or management.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. However, the lack of the active ingredient could lead to severe complications in patients requiring oxytocin.

What to Do

Healthcare providers and consumers should stop using this product immediately. Contact IntegraDose Compounding Services LLC or your healthcare provider for guidance and further instructions.

Contact Information

For more details, contact IntegraDose Compounding Services LLC at the address 719 Kasota Ave SE, Minneapolis, MN 55414-2842. Visit the FDA recall page for updates: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0015-2026.

Key Facts

  • 853 bags recalled
  • No oxytocin found in IV bags
  • Class I recall
  • Distributed nationwide in the USA
  • Immediate action required

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

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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