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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

IntegraDose Oxytocin IV Bags Recalled for Subpotency

Agency Publication Date: October 10, 2025
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Summary

IntegraDose Compounding Services LLC is recalling 853 bags of Oxytocin 30 Units in 0.9% Sodium Chloride (500 mL) because testing revealed some bags contained no oxytocin at all. This subpotent medication was distributed nationwide to healthcare facilities between September and October 2025. Healthcare providers should immediately stop using the affected bags and contact the manufacturer to arrange for a return.

Risk

The lack of oxytocin in the IV bag means patients will not receive the intended dose of this critical medication, which is used to induce or strengthen labor contractions and control bleeding after childbirth. Failure to deliver the medication as prescribed can lead to serious medical complications for both the mother and the newborn.

What You Should Do

  1. Identify the affected product by checking the label for Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use (NDC 71139-0012-1).
  2. Check for lot number 20250620OXY-1 with an expiration date of 10/18/2025.
  3. Stop using the recalled product immediately and remove it from your facility's inventory.
  4. Contact IntegraDose Compounding Services LLC or your distributor to arrange for the return of the recalled IV bags.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Variants: 30 Units/500 mL, Intravenous Use
Lot Numbers:
20250620OXY-1 (Exp 10/18/2025)
NDC:
71139-0012-1

Quantity: 853/500 mL bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97641
Status: Active
Manufacturer: IntegraDose Compounding Services LLC
Sold By: Hospitals; Surgical Centers; Wholesalers
Manufactured In: United States
Units Affected: 853/500 mL bags
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.