FDA Warns of Eye Infection Risk in 26 Eye Drop Products

FDA Warns of Eye Infection Risk in 26 Eye Drop Products

The US Food and Drug Administration (FDA) has issued a warning about 26 over-the-counter eye drop products, including those sold under store brands like CVS, Target, and Rite Aid. These products have the potential to cause a severe eye infection that may lead to vision loss or blindness.

The FDA has identified “insanitary conditions in the manufacturing facility” and detected positive bacterial test results from environmental samples taken in crucial drug production areas within the facility. As a result of these findings, the FDA is advising that the affected products be recalled.

The eye drops in question, which are marketed under various brand names including CVS Health, Rite Aid, Target Up&Up, Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma, are intended to be sterile.

As of now, there have been no reported injuries associated with the use of these products, according to the FDA. However, the agency advises that individuals experiencing signs or symptoms of an eye infection after using these products should promptly consult their healthcare provider or seek immediate medical attention.

The FDA recommends that individuals who possess these eye drops should dispose of them without delay. Major retailers like Target, Rite Aid, and CVS have already taken steps to remove these products from their store shelves and discontinue online sales. However, it’s important to note that products under the Leader, Velocity, and Rugby brands might still be available in certain stores or online, and consumers are strongly advised not to purchase them.

The FDA had previously issued a warning earlier this year, cautioning against the use of various eye drop products due to microbial contamination. According to the US Centers for Disease Control and Prevention, the use of contaminated eye drops, which contained drug-resistant bacteria, led to severe consequences, including vision loss, surgical eye removal, and even fatalities in some patients.

Eye Drop Retailers and Product Information By FDA

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
Walmart Equate Hydration PF Lubricant Eye Drop 10 ml Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops