Apollo Care FentaNYL and Ropivacaine HCl Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility

Product description

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

Lot numbers, UPCs & expiration codes

Lot AC-016878, exp date 6/16/2025

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0409-2025
Classification: Class II
Status: Ongoing
Recall initiated: Apr 15, 2025
FDA report date: May 14, 2025
Quantity: 440 bags
Recall type: Voluntary: Firm initiated
Recalling firm: Apollo Care, LLC

Original FDA data

Every field from FDA enforcement report D-0409-2025, exactly as published.

Show all FDA fields

City: Columbia
State: MO
Status: Ongoing
Country: United States
Event ID: 96754
Address: 3801 Mojave Ct Ste 101
Code information: Lot AC-016878, exp date 6/16/2025
Postal code: 65202-4042
Report date: May 14, 2025
Product type: Drugs
Recall number: D-0409-2025
Classification: Class II
Recalling firm: Apollo Care, LLC
Product quantity: 440 bags
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
Product description: FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
Distribution pattern: MO
Recall initiation date: Apr 15, 2025
Initial firm notification: Letter
Center classification date: May 6, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0409-2025, published May 14, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Apollo Care FentaNYL 500mcg Recall

Summary