Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719
Summary
The FDA issued a Class I for Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, I by IntegraDose Compounding Services LLC. Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag..
Details
Source
Drug Recall
External ID
D-0015-2026
Action Date
2025-10-22
Status
Ongoing
Category
drug
Product Description
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 Info: Lot #: 20250620OXY-1, Expiration date 10/18/2025
Quantity Affected: 853/500 mL bags
Reason for Recall
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-16
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 107 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IntegraDose Compounding Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IntegraDose Compounding Services LLC have FDA actions?
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0015-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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