CLASS I ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
Oxytocin in 0.9% Sodium Chloride for intravenous use recalled
IntegraDose Compounding Services is recalling Oxytocin in 0.9% Sodium Chloride for intravenous use, distributed nationwide in the US. The recall was initiated on 16 Sep 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0015-2026
- FDA event ID
- 97641
- Recalling firm
- IntegraDose Compounding Services, Minneapolis, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Sep 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Sep 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +24 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Which lots are affected?
Lot #: 20250620OXY-1, Expiration date 10/18/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from IntegraDose Compounding Services
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride, syringe recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD recalled | IntegraDose Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride Sterile Syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride per syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |