Cardinal Health Inc. is recalling approximately 202,345 units of various LEADER brand eye drops and irritation relief products. This recall was initiated because the FDA discovered insanitary conditions and positive bacterial test results during environmental sampling at the manufacturing facility. The products affected include Eye Irritation Relief, Dry Eye Relief, and Lubricant Eye Drops in various sizes and formulations.
Using a non-sterile eye product significantly increases the risk of serious eye infections, which could lead to vision loss or other severe health complications. Bacteria found at the manufacturing facility pose a high contamination risk to these products meant to be sterile for use in the eyes.
You have 2 options:
Distributed By Cardinal Health; Made in India
Distributed By Cardinal Health; Made in India
Distributed By Cardinal Health; Made in India
NDC 70000-0090-2 (Carton); 70000-0090-1 (Bottle)
Distributed By Cardinal Health; Made in India
Distributed By Cardinal Health; Made in India
Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%), Carton Label
Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%), Bottle Label
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%), Carton Label
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%), Bottle Label
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%), Carton Label
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%), Bottle Label
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%), 2 Bottles, Carton Label
Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%), Carton Label
Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%), Bottle Label
Lubricant Eye Drops (Propylene Glycol, 0.6%), Carton Label
Lubricant Eye Drops (Propylene Glycol, 0.6%), Bottle Label
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.