IntegraDose Compounding Services LLC drug recall: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97641
- Recall initiated
- Sep 16, 2025
- Classified by FDA
- Oct 10, 2025
- Posted in Enforcement Report
- Oct 22, 2025
- Recalling firm
- IntegraDose Compounding Services LLC
- Firm location
- Minneapolis, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 16, 2025. FDA classified it 24 days later, on Oct 10, 2025. Distribution reported by FDA: Nationwide in the USA IntegraDose Compounding Services LLC has 7 recalls in our records.
Recalled products (1)
D-0015-2026 Class I Ongoing
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
Codes / lots: Lot #: 20250620OXY-1, Expiration date 10/18/2025
Quantity: 853/500 mL bags
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 97641
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.