Park Avenue Compounding recalls Fentanyl citrate
- Recalling company
- Park Avenue Compounding
- 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.
- Reason
- CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 23, 2025
- Reported
- Nov 26, 2025
- Distribution
- Distributed in Missouri
- Status
- Ongoing
- Quantity
- 189 bags
- Lot / codes
- Lot # 20250507-01D93C, Exp Date: 11-04-2025
- Company location
- Saint Louis, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0178-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0178-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.