Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use recall
FDA recall D-0015-2026 · initiated Sep 16, 2025
IntegraDose Compounding Services LLC recalled Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use in Sep 2025 — an FDA Class I recall (D-0015-2026) because Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 853/500 mL bags
Details
- 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
- Recalling company
- IntegraDose Compounding Services LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Sep 16, 2025
- FDA report date
- Oct 22, 2025
Frequently asked
- Was Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use recalled?
- IntegraDose Compounding Services LLC recalled Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use in Sep 2025 — an FDA Class I recall (D-0015-2026) because Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use recalled?
- Per the FDA enforcement record, the reason for recall D-0015-2026 was: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
- Is a recalled Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 20250620OXY-1, Expiration date 10/18/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0015-2026.