Recalls / Class I
Class ID-0015-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot #: 20250620OXY-1, Expiration date 10/18/2025
Why it was recalled
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Recalling firm
- Firm
- IntegraDose Compounding Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 719 Kasota Ave Se, Minneapolis, Minnesota 55414-2842
Distribution
- Quantity
- 853/500 mL bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-09-16
- FDA classified
- 2025-10-10
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.