Eye Drops Removed From Shelves at CVS, Target and Rite Aid Due To Eye Infection Risk

The FDA advises consumers to avoid the potentially dangerous eye drops, which may still be available for consumers to purchase and use in some locations

Federal regulators warn that 26 different over-the-counter eye drop products sold under several popular brand names, including CVS, Target, and Rite Aid, may pose a serious eye infection risks due to bacterial contamination.

The U.S. Food and Drug Administration (FDA) issued the eye drop warning on October 27, urging consumers to avoid using or purchasing certain eye drop medications after agency investigators identified unsanitary conditions in the manufacturing facility, and sample testing confirmed bacterial contamination in drug production areas. To date, the FDA has not received any reports of adverse events or reactions in relation to the eye drop products.

FDA officials recommended the manufacturer recall the eye drops on October 25, after obtaining positive bacterial test results from the production site, and indicated that CVS, Rite Aid, and Target were in the process of removing the potentially contaminated products from their stores and websites. However, officials warn that eye drop products distributed under Leader, Rugby, and Velocity brands may still be available for purchase in stores or online, and should be avoided.

Bacterial Contamination and Eye Infection Risks

The FDA indicates the eye drop products pose risks of eye infections to consumers, which can result in partial vision loss or permanent blindness in severe cases. The potentially contaminated eye drops are applied directly into the eye, and can bypass the body’s natural defense systems, resulting in serious injuries.

The warning impacts 26 different over-the-counter eye drop products, and includes the following products distributed by CVS Health, Rite Aid, and Target Stores:

• CVS Health Lubricant Eye Drops 15 ml, Carboxymethylcellulose Sodium Eye Drops 0.5% w/v, single and twin pack varieties
• CVS Health Lubricant Gel Drops 15 ml, Carboxymethylcellulose Sodium Eye Drops 1% w/v, single and twin pack varieties
• CVS Health Multi-Action Relief Drops 15 ml, Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
• CVS Health Lubricating Gel drops 10 ml, Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
• CVS Health Lubricant Eye Drops 10 ml, Propylene Glycol Eye Drops 0.6% w/v, single and twin pack varieties
• CVS Health Mild Moderate Lubricating Eye Drops 15 ml, Polyethylene Glycol 400 Eye Drop ‘0.25% w/v, single pack variety
• Rite Aid Lubricant Eye Drops 15 ml, Carboxymethylcellulose Sodium Eye Drops 0.5% w/v, twin pack variety
• Rite Aid Lubricant Eye Drops 10 ml, Propylene Glycol Eye Drops 0.6% w/v, twin pack variety
• Rite Aid Gentle Lubricant Gel Eye Drops 15 ml, Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops
• Rite Aid Lubricant Gel Drops 15 ml, Carboxymethylcellulose Sodium Eye Drops 1% w/v
• Rite Aid Lubricating Gel Drops 10 ml, Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
• Rite Aid 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
• Target Up&Up Extreme Relief Dry Eye 15 ml, Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops, single pack variety
• Target Up&Up Extreme Relief Dry Eye 30 ml, Carboxymethylcellulose Sodium Eye Drops 0.5% w/v, twin pack variety

The warning also includes the following eye drop products distributed by Velocity Parma, LLC and Cardinal Health, sold under Rugby and Leader brands, which the FDA warns may still be available for purchase in stores and online:

• Velocity Pharma, LLC Lubricant Eye Drop 10 ml, Propylene Glycol Eye Drops 0.6% w/v, triple pack variety
• 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
• Leader (Cardinal Health) Lubricant Eye Drops 15 ml, Carboxymethylcellulose Sodium Eye Drops 0.5% w/v, single and twin pack varieties
• Leader (Cardinal Health) Dry Eye Relief 15 ml, Carboxymethylcellulose Sodium Eye Drops 1% w/v
• Leader (Cardinal Health) Eye Irritation Relief 15 ml, Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops

The agency recommends consumers properly discard the eye drops, and urges to report any quality issues experienced from use of the products to the FDA MedWatch Adverse Event Reporting program.

Eye Drop Contamination Concerns

In recent weeks, the FDA has issued several warning letters to Walgreens, CVS, Boiron, DR Vitamin Solutions, OcluMed, Similasan and TRP Company in September over manufacturing violations, including the manufacturing and distributing of unapproved eye products, illegally marketing them to treat serious eye conditions they were never approved for, distributing products that contained dangerous ingredients, and selling contaminated products.

The warning letters came amid increased scrutiny by the FDA, in response to a massive Artificial Tears eye drop recall issued in February 2023. According to a May report by the U.S. Centers for Disease Control and Prevention (CDC), the recalled Artificial Tears eye drops have been linked to 81 cases of bacterial contamination, including multiple reports of vision loss, four reports of consumers requiring removal of an eyeball, and four reports of deaths.

They also follow a similar Dr. Bernes and LightEyez MSM eye drops recall issued in August, after the eye drops were found to be contaminated with several bacterial and fungal strains, and were also found to contain the unapproved and illegally marketed active ingredient,  methylsulfonylmethane (MSM). All lots of the products were removed from the consumer market, as a result.

In the letters sent last month, Walgreens and CVS were cited for using silver as a preservative, which can cause irreversible discoloration to the skin and eyes, and were also cited for claiming certain products could relieve or treat allergies, sties, and pink eye, without prior FDA review or approval. DR Vitamin Solutions was also cited for advertising its products to treat cataracts without FDA review or approval, and several products were also found to contain N-Acetyl-Carnosine (NAC), which is not approved to treat the condition. Boiron, OcluMed, Similasan and TRP Company were cited for illegally claiming their products could treat allergies, eye irritation, and cataracts.

TRP Company was previously cited by the FDA in September 2022 for marketing several products to treat a range of eye conditions without agency review or approval, and were cited again in September 2023, after the agency identified additional variations of the products listed on the manufacturer’s website.

Officials warned the companies that the unapproved and illegally marketed products were hazardous to consumers and could cause serious or permanent eye injuries or damage, and requested that the companies respond to the warning letter within 15 days.

Artificial Tears Eye Drop Recall Lawsuits

Among former users of the contaminated Artificial Tears eye drops that prompted these recent FDA enforcement actions, a growing number of EzriCare eye drop lawsuits are now being filed by individuals who developed Pseudomonas aeruginosa infections from contaminated bottles of recalled Artificial Tears.

Lawyers are actively investigating potential eye drop infection lawsuits against the manufacturers and distributors of EzriCare and Delsam Pharma’s eye drops for multiple injuries and side effects caused by the contamination, including;

• Eye Infection
• Partial Blindness
• Permanent Blindness
• Bloodstream Infection
• Other injuries caused by the eye drops