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.

Betadine (Povidone-Iodine) 5% Recalled by Edge Pharma, LLC Due to Defective container; syringe content migrating past the seal...

Date: April 12, 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

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

Quantity: 5850 syringes

Why Was This Recalled?

Defective container; syringe content migrating past the seal of the plunger may cause a 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