FDA Warning: 27 Eye Drop Products May Cause Eye Infections

FDA Warning: 27 Eye Drop Products May Cause Eye Infections

The FDA is urging consumers to stop using 27 eye drop products because of concerns that they are not sterile and could cause eye infections. CVS Health, Walmart, Target and other brands were included in the FDA's warning, Leader (Cardinal Health) has since issued a recall. Eye infections are usually treatable, but in severe cases they can cause partial vision loss or blindness.

27 eye drop products sold at popular retailers like CVS and Target could potentially cause eye infections that can lead to vision problems, the Food and Drug Administration (FDA) warned earlier this week.

The agency urged people to stop using and discard all 27 affected eye drop products.

FDA investigators said the products — which are said to be sterile — were manufactured in an “unhygienic” facility. They found that several production areas of the facility tested positive for bacteria in environmental sample testing.

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Which eye drop products are affected?

The 27 eye drop products are sold under the following brands:

CVS HealthTarget Up & UpWalmartRite AidLeader (Cardinal Health)Rugby (Cardinal Health)Velocity Pharma

On Wednesday, Cardinal Health issued a voluntary recall of six of its eye drop products under the brand name Leader. Five of these were included in the FDA's original warning.

Cardinal Health said it has received three reports of adverse events related to the recalled eye drops.

Recalled Cardinal Health eye drops can be identified using the following information:

Eye Irritation Relief, 15ml, Product Code 70000-0087-1Dry Eye Relief, 15ml, Product Code 70000-0089-1Dry Eye Relief, 10ml, Product Code 70000-0088-1Lubricant Eye Drops, 15ml, Product Code 70000-0090-1Lubricant Eye Drops, 15 ml twin pack, product code 70000-0090-2 or 70000-0090-1Lubricant eye drops, 10 ml, product code 70000-0587-1

The company announced that these were distributed nationwide from December 12, 2021.

At this time, the other brands named in the FDA alert have not provided information regarding specific lot numbers or product codes or when the products were distributed. However, the FDA provided a complete list of each product name and its ingredient information for people to refer to.

The affected eye drops sold at Walmart, CVS, Rite Aid and Target will be removed from store shelves and each company's website. However, the Leader, Rugby and Velocity eye drop products may still be available but should not be purchased.

Leader (Cardinal Health) said it was “initiating the return of the recalled products” and called on any distributors or retailers to stop selling their recalled eye drops.

Aside from the three side effects associated with Leader brand eye drops (Cardinal Health), the FDA reports no other associated eye infections. However, healthcare providers and users of the products are asked to document any side effects via the FDA's MedWatch site.

"Our manufacturing facilities should be sterile. And these drops should come off [manufacturing] lines that are sterile," said Loretta Szczotka-Flynn, OD, PhD, Searle Huang Professor of Ophthalmology and Vision Sciences and director of the Coordinating Center for Vision Research at Case Western Reserve University School of MedicineHealth.

“You stop a problem before it occurs,” she added.

The agency originally recommended the manufacturer recall the eye drops on Oct. 25 and issued its first safety warning on Friday. That statement covered 26 eye drop products, and the Walmart brand eye drops were added to the list on Monday.

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Why are unsterile eye drops a problem?

This announcement from the FDA is the second to sound the alarm about eye drop safety in recent months - in late August, the agency warned customers to stop using Dr. Dr.'s eye drops due to a similar problem. Avoid Berne’s and LightEyez.

And in early February, the Centers for Disease Control and Prevention (CDC) urged people to stop using EzriCare eye drops after bacterial contamination in the product was linked to a number of hospitalizations and one death.

Due to the severity of this outbreak, the FDA appears to be increasing its oversight, according to Szczotka-Flynn.

“We hadn’t seen anything like this in our area for a long time,” she said.

Although it has not been confirmed by the agency, the FDA appears to be conducting more investigations into private label manufacturers or less established eye drop manufacturers, Szczotka-Flynn said.

With eye drops in particular, it is important for authorities to address potential sterility issues because "medications applied to the eyes bypass some of the body's natural defenses," according to the FDA.

In the case of the EzriCare eye drops, the product was contaminatedPseudomonas, a type of bacteria that ended up being resistant to many common antibiotics, Szczotka-Flynn said. This made it difficult for medical professionals to treat the eye infections quickly.

In its most recent warning, the FDA did not disclose what type of bacteria was found in the manufacturing facility, nor did it specifically state that bacteria were found in the eye drops themselves.

Still, the FDA warning is an extreme precaution. Contact lens wearers in particular are more susceptible to bacterial keratitis, an infection of the cornea caused by bacteria. In very severe cases, this infection can cause a person to need a corneal transplant or even lead to blindness.

Typically, Szczotka-Flynn said, these infections are treatable with antibiotics.

Even with these 27 eye drop products named in the FDA warning, people should throw away any products they have at home and avoid any eye drop products from Leader, Rugby and Velocity that may still be on shelves or online.

In general, however, there is no need to exercise caution when using eye drops, emphasized Szczotka-Flynn. These more frequent FDA warnings mean that the agency's regulatory investigations are working properly to prevent potential health problems.

Szczotka-Flynn said larger manufacturers and well-known brand eye drop products in particular have quality control and sterilization practices that are essentially "impeccable." The risk of bacterial contamination is low with these household eye drop brands.

“I don’t want people to worry about artificial tears,” she said. “We prescribe them all the time and there are safe, very good artificial tears on the market today.”

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