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.

FDA recall notice · announced December 10, 2025 · Park Avenue Compounding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

CGMP Deviations

Notes

Distribution: MO
Lot/code information: Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Quantity: 858 syringes
Status: Ongoing
Products in this recall event:
- 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. (D-0200-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.