Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compou...

FDA Recall #D-0015-2026 — Class I — September 16, 2025

Recall #D-0015-2026 Date: September 16, 2025 Classification: Class I Status: Ongoing

Product Description

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

Reason for Recall

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Recalling Firm

IntegraDose Compounding Services LLC — Minneapolis, MN

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

853/500 mL bags

Distribution

Nationwide in the USA

Code Information

Lot #: 20250620OXY-1, Expiration date 10/18/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated