FDA warns consumers against using 27 eye drop products because of infection risk

Federal regulators are warning consumers to stop using a number of over-the-counter eye drops that may pose an infection risk, marking the latest of several alerts this year against artificial tears.

The notice applies to 27 eye drop products marketed under several store brands, such as CVS Health, Rite Aid, Target Up & Up and Walmart Equate, in addition to the Leader, Rugby and Velocity Pharma brands, the Food and Drug Administration said Friday. The eye drops may contain bacteria that could cause eye infections, potentially causing vision loss or even blindness, the agency said. 

The FDA said it has not received any reports of infections from consumers who have used the suspect products. However, the agency is recommending that manufacturers pull all potentially contaminated products from store shelves. 

According to the FDA, federal investigators found harmful bacteria and “insanitary conditions” at a factory where several eye drop products are made. The agency said it advised the manufacturer to recall the products. 

CVS, Rite Aid and Target are removing the products from their stores and websites, but items branded as Leader, Rugby and Velocity may still be available for sales, according to the FDA.

The agency urged consumers who have purchased the potentially contaminated eye drops to discard them. The FDA said that consumers who think they have suffered an adverse reaction to the lubricants should report their concerns to the agency’s MedWatch Adverse Event Reporting program. 

Eye infection symptoms may include eye pain or discomfort, discharge, blurry vision, sensitivity to light, the feeling of a foreign object in the eye, as well as redness or swelling of the eye or eyelid, according to the Centers for Disease Control and Prevention.

The alert follows a series of eye drop recalls the FDA issued earlier this year after federal health investigators found evidence that several products were contaminated with a dangerous drug-resistant bacteria known as Pseudomonas aeruginosa. Eye drops tainted with the bacteria are linked to the death of at least four people, with dozens more affected across 18 states, CDC data shows. 

“This is infuriating for a few reasons,” Teresa Murray, consumer watchdog at U.S. PIRG Education Fund, in a statement. “First, prior to this FDA warning, there have been three major eye drop recalls this year for bacterial contamination or unsterile products. Why has it taken this long for the FDA to discover this much broader problem?” 

“Second, this points to the need for the FDA to have authority to recall unsafe prescriptions and over-the-counter medications when companies — for example, this eye drop manufacturer — refuse to cooperate in a timely fashion,” she added.

The FDA’s latest warning applies to the following eye drop products sold throughout the U.S. 

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
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

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