2023 FDA OTC Eye Drops Recalls and What It Means for Eye Health
Last year saw the recall of dozens of over-the-counter (OTC) eye drops, some of which caused infections leading to vision loss, blindness, and death.
The recalls began in February and reached a peak in October when the Food and Drug Administration (FDA) took off the shelves more than a dozen OTC eye drops.
Today, we take a closer look at the 2023 eye drops recalls to understand when eye drops can be dangerous and what alternatives you have. Let’s start with the facts.
Timeline of 2023 FDA OTC Eye Drops Recalls
The year 2023 had barely started when Global Pharma Healthcare recalled three EzriCare and Delsam Pharma artificial tears eye drops due to potential microbial contamination. It was only the beginning of what would become a major health issue.
By May 19, 81 people developed highly drug-resistant bacterial infections from using contaminated eye drops mostly sold online. Fourteen of these people lost their sight, four needed to have their eyes removed through surgery, and another four died.
Things didn't end there. Late August saw the recall of two methylsulfonylmethane (MSM) eye drops, LightEyez MSM Eye Drops – Eye Repair and Dr. Berne’s MSM Drops 5% Solution, also due to bacterial contamination. In the US, eye drops using the active ingredient methylsulfonylmethane are banned and illegal.
Then on October 27, 2023, the FDA warned consumers not to buy and to stop using 26 over-the-counter eye drops. By November 3, 2023, the FDA warned against a few more products.
All of these products carry the risk of eye infections that can lead to vision loss and blindness. Consumers who already bought them were advised to stop using them at once and throw away the bottles.
The OTC eye drops in question came from the brands CVS Health, Leader (Cardinal Health), Rugby (Harvard Drug Group), Rite Aid, Target, Velocity Pharma LLC, and Walmart. They included lubricating eye drops and gels, multi-action relief drops, eye irritation relief drops, and dry eye drops.
When Do Eye Drops Cause Eye Infections?
Eye drops and eye gels are supposed to be sterile, that is, free from germs. Contamination can occur during the manufacturing process and at any point after.
The FDA investigators found insanitary conditions in the manufacturing facility where some of the above-mentioned eye drops were being made. What’s more, investigators found bacteria in drug production areas.
More than causing eye infections, contaminated eye drops can lead to other health problems because they are applied directly to the eyes, which bypasses some of the body’s immune defenses.
Infections from eye drops remain rare, but when they occur, they can have severe consequences because of their resistance to treatment.
Eye drop formulations also have to be stable to retain their properties. Most eye drops are packaged in multi-use bottles. This often means that they contain preservatives.
Do the 2023 Eye Drops Recalls Mean You Should Stop Using Eye Drops?
The products recalled were OTC eye drops from little-known brands and store brands. Major pharmaceutical companies that make eye drops like Alcon, Johnson & Johnson, or Allergan haven’t run into this kind of problem. For example, there has never been a Visine eye drops recall.
Also, it’s important to highlight that no prescription eye drops have been recalled in 2023. Prescription eye drops can be a critical component in the treatment of eye infections and other eye diseases.
With that in mind, even eye drops deemed safe can be bad for your eyes sometimes. A good example is dry eye drops containing preservatives like benzalkonium chloride (BAK).
Manufacturers use BAK and other preservatives to maintain eye drops sterile. Without preservatives, most formulations would only be available as a single-use dose unless packaged in special delivery bottles like ABAK or COMOD.
The use of eye drops with BAK has been associated with tear film disruption, corneal toxicity, and other eye problems. In other words, long-term use of BAK to treat dry eyes can make dry eyes worse.
No fewer than 120.55 million Americans used eye drops and eye wash in 2020, with this number projected to increase to 123.35 million by 2024 according to Statista.
Was the use of eye drops necessary in each of these cases? Probably not. Would there have been alternative treatment options at least for some of the patients? Yes.
Is There an Alternative to Eye Drops?
When an eye doctor prescribes you eye drops, it’s for a reason and you should take the treatment. Remember that most eye doctors stay up to date with FDA drug recalls and are among the first to know when they happen.
If you have any concerns about the eyes and vision product you’ve been prescribed, discuss them with your doctor. In many cases, other options will be available.
By contrast, OTC eye drops that you can buy without a prescription may not always be necessary. Safe artificial tears may soothe dry eye symptoms, but they won’t address the underlying cause of dry eye disease.
A healthy diet can be a great way to nourish your eyes. You can find out more about foods good for the eyes in our post on the best foods for eye health.
Alongside a healthy diet, an eye health supplement may even help with improving eyesight naturally by providing your eyes with lutein and zeaxanthin. These carotenoids (a type of antioxidant) occur in the part of the eye responsible for the sharpest vision, the macula within the retina.
Studies show that taking in more carotenoids as a supplement may improve night vision at least in some groups of people. Good night vision is important for driving safely at night.
SightC is a plant-based, natural eye health supplement that brings together antioxidants and key nutrients from goji berries, turmeric, and other superfoods. These nutrients support the health of eye cells and tear glands.
Learn more about SightC and how it can help keep your eyes healthy.