Eye Drops Recall 2023: Reasons, brand, and all you need to know

Cardinal Health, Inc. has issued a nationwide recall for its eye drops over potential bacterial contamination concerns. Supplied under Cardinal Health's subsidiary company, Velocity Pharma, LLC, the affected products could put people at risk of experiencing eye infections that could lead to permanent blindness.

Announced earlier this month, the voluntary recall is linked to the findings of an investigation conducted by the United States Food and Drug Administration (FDA). The federal agency is investigating an eye infection outbreak caused by using ophthalmic drugs affected by bacterial contamination.

As the investigations continued, the establishment was informed that federal investigators found its manufacturing facilities unsanitary. The environmental sampling tests conducted in crucial production areas tested positive for bacterial contamination. As such, Cardinal Health, Inc. was compelled to initiate a recall for nearly all LEADER™ branded ophthalmic drugs distributed over the last few years to ensure consumer safety.

The Eye Drops affected by this recall could cause partial to permanent blindness (Image via FDA)

It is to be noted that all ophthalmic drugs must be sterile, as drugs applied to the eyes can bypass several crucial natural defenses of the human body. As such, eye drops affected by bacterial contamination could cause eye infections and result in partial to permanent blindness. The establishment has already received at least three reports of adverse effects caused by the recalled products.

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All you need to know about Cardinal Health's Eye Drops Recall

Nearly all ophthalmic drug products supplied by the Cardinal Health subsidiary, Velocity Pharma, LLC, are being recalled nationwide. Reportedly affected by bacterial contaminants, the affected products may pose a risk of eye infections that can even lead to incurable blindness.

Packed in plastic bottles, which were further packed in labeled white boxes, the affected eye drops were available under the LEADER™ brand. Sold as over-the-counter (OTC) drugs, these products were intended for several eye-related problems like dry eyes, irritation, and burning in the eyes. These drugs were also used to cure redness in the eyes.

The recalled eye drop products were sold as OTC drugs to cure eye irritation and other similar problems (Image via FDA)

Consumers can refer to the following table for a list of all affected products:

Product Name	PackageDescription	BrandName	NDC
Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0087-1
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0089-1
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0090-1
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%)	2 bottles, 0.5 FL OZ (15 mL) each	LEADER™	70000-0090-2 (Carton) 70000-0090-1 (Bottle)
Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%)	0.33 FL OZ bottle (10 mL)	LEADER™	70000-0088-1
Lubricant Eye Drops (Propylene Glycol, 0.6%)	0.33 FL OZ bottle (10 mL)	LEADER™	70000-0587-1

Distributed to all major retailers and wholesalers nationwide, the eye drops affected by this recall have been available for purchase since December 12, 2021. Cardinal Health, Inc. is notifying all concerned retailers and wholesalers about the recall and arranging for the return of all affected lots.

Consumers, on the other hand, are urged not to use the recalled ophthalmic drugs any longer. All affected bottles should be disposed of or returned to the concerned retailers for reimbursement. People who regularly need these eye drops are advised to consult their pharmacists for alternatives.

Individuals who may still need some assistance regarding the recall can contact the establishment at 1-855-215-4940. The establishment is reachable from Mondays to Fridays during the working hours of 8:00 am and 5:00 pm EST.