Class IIOngoing

PHENYLephrine HCl in 0.9% Sodium Chloride recall

FDA recall D-0372-2025 · initiated Mar 31, 2025

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

Why it was recalled

Lack of Assurance of Sterility: Leaking/damaged syringes.

Details

Product: PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Recalling company: Denver Solutions, LLC DBA Leiters Health
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the U.S.A
Initiated: Mar 31, 2025
FDA report date: Apr 30, 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-0372-2025 ↗

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