The Recall Desk
CriticalFDA (Drugs)·D-0015-2026·Announced 2025-10-22

Compounded oxytocin bags recalled after testing found no oxytocin present

IntegraDose Compounding Services is recalling 853 bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride after testing revealed there was no oxytocin in the IV bag.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, from IntegraDose Compounding Services of Minneapolis, Minnesota, is being recalled as a subpotent drug. Testing revealed there was no oxytocin in the IV bag.

The recall covers 853 500 mL bags from lot 20250620OXY-1, expiring 18 October 2025, carrying NDC 71139-0012-1. The product was distributed nationwide in the United States. The FDA has classified the recall as Class I.

Oxytocin is given intravenously in obstetric care, so a bag containing none of the drug would deliver no treatment at all while appearing to be in use.

Facilities holding the affected lot should quarantine it immediately and follow the firm's instructions.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.