Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Phenylephrine HCI Recalled by Park Avenue Compounding Due to CGMP Deviations

Date: September 17, 2025
Company: Park Avenue Compounding
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Park Avenue Compounding directly.

Affected Products

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.

Quantity: 858 syringes

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed to 1 state: MO

Affected (1 state)Not affected

About Park Avenue Compounding

Park Avenue Compounding has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report