Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5% Recalled by Cardinal Health Inc. Due to Non-Sterility: FDA found insanitary conditions and positive bacterial...

Date: October 31, 2023
Company: Cardinal Health Inc.
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 Cardinal Health Inc. directly.

Affected Products

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1

Quantity: 11629 units

Why Was This Recalled?

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

Related Recalls

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