Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII

Park Avenue Compounding has recalled Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 26, 2025 and was initiated on September 23, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, with approximately 189 bags affected. The company behind the recall is Park Avenue Compounding, based in Saint Louis, MO. The FDA describes the product as: “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.”

Why was Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII recalled?

According to the FDA, the stated reason for the recall is: “CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).

CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.

What should you do?

If you think you may have bought Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, compare it against the product description and identifying codes (Lot # 20250507-01D93C, Exp Date: 11-04-2025) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Park Avenue Compounding or your local health authority.

About this recall

This recall was distributed in MO. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.