Class IIOngoing

Phenylephrine HCI recall

FDA recall D-0200-2026 · initiated Sep 17, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations

Details

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.
Recalling company: Park Avenue Compounding
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: MO
Initiated: Sep 17, 2025
FDA report date: Dec 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0200-2026 ↗

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