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Drug FDA Class I Ongoing Sub/super-potent

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

IntegraDose Compounding Services LLC Published Oct 22, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact IntegraDose Compounding Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Subpotency · primary

Affected products (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

853/500 mL bags

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

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 16, 2025
  2. Published
    Oct 22, 2025
Recall number
D-0015-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.