September 2025 FDA Recall Drug by Integradose Compounding Services Llc
D-0015-2026 - Subpotent Drug

This Class I drug recall was voluntarily initiated by Integradose Compounding Services Llc on September 16, 2025 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0015-2026

Reason for Recall
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Initiated
09-16-2025
Reported
10-22-2025
Quantity
853/500 mL bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97641
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
IntegraDose Compounding Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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