Warning
Park Avenue Compounding Recalls Fentanyl citrate
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0178-2026Drug / Pharmaceutical
Park Avenue Compounding Recalls Fentanyl citrate
Park Avenue Compounding · Class II — Moderate Risk
Product Description
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.
Reason for Recall
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Distributed in Missouri
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Park Avenue Compounding initiated the recall on September 23, 2025 affecting 189 bags. CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. The product was distributed in Distributed in Missouri. Consumers should check their purchases and discontinue use of any affected product. Contact Park Avenue Compounding for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.