Park Avenue Compounding recalls Phenylephrine HCI
- Recalling company
- Park Avenue Compounding
- Product
- Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
- Reason
- CGMP Deviations
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 17, 2025
- Reported
- Dec 10, 2025
- Distribution
- MO
- Status
- Ongoing
- Quantity
- 858 syringes
- Lot / codes
- Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- Company location
- Saint Louis, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0200-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0200-2026 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.