Class II · Moderate risk
Oxytocin for Injection
Lack of Assurance of Sterility
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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 NDC
71139-0012-01
Compare with the code on your package — it is the most precise check available.
Drug: Oxytocin
- Recalling firm
- IntegraDose Compounding Services LLC
- NDC code
- 71139-0012-1
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0015-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Oxytocin recalls
See all
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class III · Low risk
Oxytocin synthetic
Labeling: Not Elsewhere Classified
Class II · Moderate risk
oxyTOCIN
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Other recalls by IntegraDose Compounding Services LLC
All 2025 recalls
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate 2
Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
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