FDA warns eye drops may cause infection. Here’s a list of 27 products to which the alert applies.

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. 

Details on the FDA warning

According to the FDA, federal investigators found harmful bacteria and what they described as “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 to watch out for

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.

List of eye drop products in latest FDA warnings

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

List of previously recalled eye drop products

The latest recalls follow a spate of FDA warnings earlier this year against using several eye drop brands linked to an outbreak of drug-resistant bacteria. The outbreak is linked to at least 4 deaths across 18 states and dozens of infections. Previously recalled brands include: 

• EzriCare and Delsam Pharma “Artificial Tears Lubricant Eye Drops.” Global Pharma Healthcare on February 2 recalled all lots of its EzriCare and Delsam Pharma brands of “Artificial Tears Lubricant Eye Drops” which it said could be contaminated with bacteria. 
• Delsam Pharma “Artificial Eye Ointment.” Global Pharma on February 24 also recalled one batch of a product distributed by Delsam Pharma, “Artificial Eye Ointment,” again due to possible microbial contamination.
• Apotex “Brimonidine Tartrate Ophthalmic Solution, 0.15%.” Another manufacturer, Apotex, on March 1 recalled six lots of its own brand of glaucoma drops, called “Brimonidine Tartrate Ophthalmic Solution, 0.15%,” which is for patients with open-angle glaucoma or ocular hypertension.
• Pharmedica “Purely Soothing, 15% MSM Drops.” Pharmaceutical firm Pharmedica USA on March recalled two lots of “Purely Soothing, 15% MSM Drops,” also over sterility concerns. 
• Dr. Berne’s Whole Health Products “Dr. Berne’s MSM Drops 5% Solution.” Dr. Berne issued a voluntary recall of the Dr. Berne’s MSM Drops 5% Solution, after FDA testing found evidence of bacterial and fungal contamination that pose a serious health risk, including vision- and life-threatening infections. The company expanded its recall in August to include four different products: MSM Drops 5% and 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM Mist 15% Solution.
• LightEyez Limited “LightEyez MSM Eye Drops – Eye Repair.” The FDA in August issued a warning to consumers to immediately stop using the London-based manufacturer’s eye drop products because of potential bacterial or fungal contamination.

A comprehensive list of eye drops recalled in 2023 can be found here.