FDA Recall D-0015-2026

IntegraDose Compounding Services LLC · Minneapolis, MN

Class I — life-threatening Ongoing 240 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

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

Quantity: 853/500 mL bags

Reason for recall

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

Recall record

Recall number: D-0015-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-09-16
Classified by FDA Center: 2025-10-10
FDA published: 2025-10-22
Recalling firm: IntegraDose Compounding Services LLC
Firm location: Minneapolis, MN

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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