Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Apollo Care Fentanyl and Ropivacaine Injection Recalled for Sterility Concerns

Agency Publication Date: May 6, 2025
Share:
Sign in to monitor this recall

Summary

Apollo Care, LLC is recalling 440 bags of FentaNYL (500mcg) and Ropivacaine HCl (250mg) added to 250 mL of 0.9% Sodium Chloride Injection. This medication is intended for epidural use and was distributed to healthcare facilities in Missouri. The recall was initiated because the company cannot guarantee that the product is sterile. If a medication meant for injection is not sterile, it could contain harmful microorganisms that cause serious infections.

Risk

The use of a non-sterile injectable product can lead to life-threatening infections, including meningitis or spinal abscesses. While no injuries have been reported, the lack of sterility assurance poses a significant health risk to patients receiving this epidural medication.

What You Should Do

  1. This recall affects 250 mL bags of FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) in 0.9% Sodium Chloride Injection (NDC 71170-950-25). Only lot AC-016878 with an expiration date of 6/16/2025 is included in this recall.
  2. Stop using the recalled product immediately and quarantine any remaining inventory to prevent further use.
  3. Contact the manufacturer, Apollo Care, LLC, or your distributor to arrange for the return of the affected bags.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

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: FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection
Variants: 250 mL bag, For Epidural Use Only
Lot Numbers:
AC-016878 (Exp 6/16/2025)
NDC:
71170-950-25

Quantity: 440 bags. Manufactured in Columbia, MO.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96754
Status: Active
Manufacturer: Apollo Care, LLC
Sold By: Hospitals; Infusion Centers; Healthcare Providers
Manufactured In: United States
Units Affected: 440 bags
Distributed To: Missouri

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.