The Recall Desk
HighFDA (Drugs)·D-0178-2026·Announced 2025-11-26

Fentanyl-Ropivacaine Compounded Medication Recalled Due to Manufacturing Deviations

Park Avenue Compounding is recalling 189 bags of compounded fentanyl and ropivacaine due to manufacturing process deviations. The medication was distributed in Missouri with an expiration date of November 4, 2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of a potent controlled substance due to manufacturing process deviations. While no illnesses or injuries have been reported, CGMP deviations in the production of fentanyl represent a risk-of-harm scenario where product quality and potency cannot be assured.

Plain-English summary

Park Avenue Compounding is recalling 189 bags of a compounded medication containing fentanyl citrate 2 mcg/ml and ropivacaine 0.2% in saline solution. This is a prescription-only product supplied in 150 mL bags with NDC 83863-4272-1, manufactured at the company's location at 3662 Park Avenue, Saint Louis, Missouri.

The recall was issued due to manufacturing deviations identified in Good Manufacturing Practice (CGMP) standards, related to a revised interpretation of Acceptable Quality Level (AQL) results. The FDA has designated this as a Class II recall.

The recalled medication was distributed in Missouri. The affected batch is identified by lot number 20250507-01D93C, with an expiration date of November 4, 2025.

Healthcare providers who received this product should contact Park Avenue Compounding regarding replacement or alternative sourcing. Patients should consult their healthcare provider if they have received doses from this lot.

The recalled product

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.
Manufacturer
Park Avenue Compounding
Category
Drug — Compounded Medication
Hazard
  • cgmp-deviation
  • quality-control-issue

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distribution scope not specified by the agency.

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