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

Recall Insight

This FDA Drug action (record #D-0015-2026) was formally reported on October 22, 2025, with the manufacturer initiating the action on September 16, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. IntegraDose Compounding Services LLC is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 853/500 mL bags units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.