FDAClass IINovember 26, 2025

Fentanyl citrate recall: CGMP Deviations

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…

Why was Fentanyl citrate recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 20250507-01D93C, Exp Date: 11-04-2025

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…
Recalling firm
Park Avenue Compounding
Quantity
189 bags
Distribution
Distributed in Missouri
Recall date
November 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls