FDA warns consumers to stop using dozens of over-the-counter eye drops

by Lara Bonatesta - 10/30/23 10:19 AM ET

(WHTM) – The U.S. Food and Drug Administration is urging consumers to stop using 26 over-the-counter eye drop products from multiple major brands due to the risk of eye infections that may lead to vision loss or blindness.

The FDA first posted the warning Friday, explaining that officials had already urged the manufacturer to recall the affected products days before. The move came “after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility,” the FDA wrote.

The eye drop products were marketed under the following brands:

CVS Health
Leader (Cardinal Health)
Rugby (Cardinal Health)
Rite Aid
Target Up&Up
Velocity Pharma

CVS, Rite Aid and Target were in the process of removing the affected products from sale as of Friday, according to the FDA. The agency said, however, that Rugby, Leader and Velocity Pharma products may still be on the market.

The specific products affected by the warning are listed below.

Retailer/ Label	Product	Product Information
CVS Health	Lubricant Eye Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Gel Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Lubricant Gel Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Multi-Action Relief Drops 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
	Lubricating Gel drops 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Lubricant Eye Drops 10 ml (single pack)	Propylene Glycol Eye Drops 0.6% w/v
	Lubricant Eye Drops 10 ml (twin pack)	Propylene Glycol Eye Drops 0.6% w/v
	Mild Moderate Lubricating Eye Drops 15 ml (single pack)	Polyethylene Glycol 400 Eye Drop ‘0.25% w/v
Rugby (Cardinal Health)	Lubricating Tears Eye Drops 15 ml	Hypromellose 2910-0.3% w/v & Dextran 70- 0.1% Eye Drops
Rugby (Cardinal Health)	Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml	Polyvinyl Alcohol Eye Drops 1.4% w/v
Leader (Cardinal Health)	Dry Eye Relief 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Lubricant Eye Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Dry Eye Relief 15 ml	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Eye Irritation Relief 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Rite Aid	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 10 ml (twin pack)	Propylene Glycol Eye Drops 0.6% w/v
	Gentle Lubricant Gel Eye Drops 15 ml	Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops
	Lubricant Gel Drops 15 ml	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Lubricating Gel Drops 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Multi-Action Relief Drops 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Target	Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Up&Up Extreme Relief Dry Eye 15 ml (single pack)	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Up&Up Extreme Relief Dry Eye 30 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
Velocity Pharma LLC	Lubricant Eye Drop 10 ml (triple pack)	Propylene Glycol Eye Drops 0.6% w/v

As of Oct. 27, the FDA has not received any “adverse event reports of eye infection” connected with the eye drops.

Still, the agency is telling consumers to discard the drops.

Consumers and health providers should also report any negative reactions to the FDA’s MedWatch Adverse Event Reporting program, either online or via fax.