Fentanyl citrate recall — Class II (D-0178-2026) · pharmaranks
Class IIOngoing
Fentanyl citrate recall
FDA recall D-0178-2026 · initiated Sep 23, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Details
Product
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.
Recalling company
Park Avenue Compounding
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Distributed in Missouri
Initiated
Sep 23, 2025
FDA report date
Nov 26, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.