FDA Recalls Over 3 Million Eye Drop Bottles: What You Need to Know

A drug company in California is recalling more than 3.1 million bottles of over-the-counter eye drops because of concerns that they may not be sterile.

The Food and Drug Administration (FDA) announced that K.C. Pharmaceuticals is voluntarily pulling the products. They were sold at major stores such as Walgreens, Kroger, and CVS.

The recall started on March 3 and was officially classified by the FDA on March 31. Experts say the FDA’s alert shows both uncertainty and caution.

“We don’t know if they actually were contaminated. If they were, we don’t know what kind of germ. We don’t know any of that. All we know is the manufacturer said there’s a problem with sterility in these products,” said Gary Novack, PhD, a clinical professor at the UC Davis Department of Ophthalmology and Vision Science.

Which eye drop brands are affected?

No injuries or illnesses have been reported from these products. The recalled eye drops include:

– Sterile Eye Drops AC

– Eye Drops Advanced Relief

– Dry Eye Relief Eye Drops

– Ultra Lubricating Eye Drops

– Sterile Eye Drops Original Formula

– Sterile Eye Drops Redness Lubricant

– Sterile Eye Drops Soothing Tears

– Artificial Tears Sterile Lubricant Eye Drops

If you have any of these, stop using them and throw them away.

The FDA labeled this a “Class II” recall. That means using the drug could cause temporary health problems, but the chance of a serious issue is low. The reason for the recall is listed as “lack of assurance of sterility.” This does not mean the drops are proven to be contaminated. It means there may have been a problem in the manufacturing process that could affect sterility.

Retailers are helping customers with next steps. A CVS representative said the four recalled items sold at their stores were discontinued nearly a year ago, but customers can return them for a refund. Walgreens and Kroger did not respond to requests for comment.

Why doctors are concerned about eye drop safety

Even though no one has gotten sick from this recall, experts say wide recalls can cause other problems.

“It’s always concerning any time we have a recall of clinical products,” said Sylvia Groth, MD, executive medical director of the Department of Ophthalmology at Vanderbilt University Medical Center. “These events erode patient trust in over-the-counter medications. I am worried that when I prescribe or recommend a treatment, it can be weakened by a recall.”

Over-the-counter eye drops do not need FDA review like prescription eye drops do. But they still must follow manufacturing rules to ensure quality and purity.

Prescription eye drops are not part of this recall. Anyone using them should feel safe continuing their treatment.

“They’re not at risk,” Novack said. “We don’t want patients to stop using their prescription eye drops for glaucoma, dry eye, or infection. It doesn’t apply to them.”

Still, both doctors and consumers have reason to be cautious. In 2023, a major bacterial outbreak linked to over-the-counter eye drops caused more than 80 infections, 14 cases of vision loss, and four deaths.

Novack, who wrote about that outbreak in the journal Ophthalmology, called it a “perfect storm.” He pointed to several failures: The manufacturer sold a product that did not meet federal rules, and the facility was contaminated with antibiotic-resistant bacteria. Also, during the COVID-19 pandemic, the FDA paused inspections of manufacturing sites, which may have let safety problems go unnoticed.

Signs of an eye infection

If you used one of the recalled products and are worried about an eye infection, watch for these symptoms:

– Discharge from the eye

– Pain or discomfort

– Redness or swelling

– Blurry vision

But these symptoms can also be caused by other issues, like allergies, Groth said. “Patients can get very bad allergies, especially this time of year, that can look like an infection. If it is an allergy, it can be bothersome but doesn’t need antibiotics.”

She added that it’s important to track your symptoms. If they don’t get better, see a doctor.

Contact lens wearers should be extra careful. “I’m always more worried about my contact lens patients than an otherwise healthy person using artificial tears,” Groth said. “If you wear contacts, you’re at higher risk because you can have small scratches or ulcers on your eye, and contacts can hold bacteria.”

She also encouraged everyone to practice good hygiene when using eye drops. Here are some tips:

– Wash your hands.

– Don’t touch your eye or eyelashes with the tip of the bottle.

– Throw away single-use products right after using them.

– Choose well-known brands or ask your doctor for a recommendation.