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 HCl Recalled by Edge Pharma, LLC Due to Lack of Assurance of Sterility

Date: December 6, 2021
Company: Edge Pharma, LLC
Status: Terminated
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 Edge Pharma, LLC directly.

Affected Products

Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10

Quantity: 6535 vials

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edge Pharma, LLC

Edge Pharma, LLC has 62 total recalls tracked by RecallDetector.

Related Recalls

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