Leader brand Eye Irritation Relief

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Non-Sterility

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

Affected NDC 70000-0087-01

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Eyes Irritation Relief Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride NDC 70000-0087	POLYVINYL ALCOHOL, UNSPECIFIED 5 mg/mL; POVIDONE, UNSPECIFIED 6 mg/mL; TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL	Liquid Ophthalmic	Cardinal Health 110, LLC. Dba Leader	OTC

Recalling firm: Kilitch Healthcare India Limited
NDC code: 70000-0087-1
Origin: India
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0297-2024 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.