If you use over-the-counter (OTC) eye drops to relieve dryness, irritation, or redness, you should check the label of your product. The FDA has warned consumers not to use certain OTC eye drop products due to the potential risk of eye infections resulting in vision loss or blindness.
What are the affected products?
The affected products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target
- Up & Up
- Velocity Pharma
These products are intended to be sterile and contain various active ingredients, such as carboxymethylcellulose sodium, polyvinyl alcohol, povidone, tetrahydrozoline hydrochloride, polyethylene glycol, and propylene glycol. They are used to lubricate, moisturize, or relieve symptoms of dry eyes, eye allergies, or eye irritation.
Why are these products recalled?
These products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
These products are intended to be sterile. Because drugs applied to the eyes bypass some of the body’s natural defenses, ophthalmic drug products pose a potentially heightened risk of harm to users.
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, 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. FDA also recommends consumers discard these products properly.
CVS, Rite Aid, and Target are removing the products from their store shelves and websites. Products branded Leader, Rugby, and Velocity may remain available in stores and online and should not be purchased.
The FDA has not received any reports of these products’ adverse events or eye infections. Still, it advises consumers to stop using them immediately and properly discard them. If you have used any of these eye drops and have any signs of an eye infection you should seek medical care with your eye doctor as soon as possible.
What are the signs and symptoms of an eye infection?
Some common signs and symptoms of an eye infection include:
- Redness of the eye or eyelid
- Swelling of the eye or eyelid
- Pain or discomfort in the eye or eyelid
- Discharge from the eye, which may be clear, yellow, or green.
- Crusting of the eyelashes or eyelids
- Sensitivity to light
- Blurred vision or difficulty seeing
- Fever, headache, or sore throat
Some eye infections can be severe and cause permanent vision loss. Therefore, seeking medical attention immediately is essential if you experience these symptoms.
What are some safe and effective alternatives to these products?
The FDA warns consumers not to use any OTC products that claim to treat severe eye conditions, such as glaucoma, cataracts, retinopathy, or macular degeneration, as no OTC treatments exist for these conditions.
How to stay updated on the latest recalls and warnings?
The FDA actively monitors eye drops and other products in the marketplace by conducting surveillance, sampling, testing, and inspecting. The agency may recommend voluntary recalls to remove products from the market if they pose a safety risk to consumers.
You can stay updated on the latest recalls and warnings by visiting the FDA website or subscribing to the FDA email alerts. You can follow the FDA on social media, such as Twitter, Facebook, or YouTube, for the latest news and information.