FentaNYL 500mcg and Ropivacaine HCl 250mg added to recalled over sterility concerns

Recall date

April 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apollo Care, LLC recalls FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidura…

Recall number

D-0409-2025

FDA classification

Class II

Brand / firm

Apollo Care, LLC

Sold / distributed

MO

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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