FDA Drugs recall ·
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0015-2026
- Date
- (initiated September 16, 2025)
- Company / brand
- IntegraDose Compounding Services LLC
719 Kasota Ave Se, Minneapolis, MN, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 853/500 mL bags
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 20250620OXY-1, Expiration date 10/18/2025
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0015-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.