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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97641

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 16, 2025
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
IntegraDose Compounding Services LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0015-2026
Recall number
D-0015-2026
Initiated
September 16, 2025
Classification
Class I
Status
Ongoing
Quantity
853/500 mL bags

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide in the USA