Fentanyl citrate recalled over manufacturing violations

Recall date

September 23, 2025

Source

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

Official notice title

Park Avenue Compounding recalls Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662…

Recall number

D-0178-2026

FDA classification

Class II

Brand / firm

Park Avenue Compounding

Sold / distributed

Distributed in Missouri

Why it was recalled

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

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 citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.