FDA Warns Consumers to Stop Using 26 Different Eye Drop Products

What caused the FDA warning?

On October 25, 2023, the FDA urged the manufacturer of the eye drops to perform a total recall of the affected products. During an inspection of manufacturing facilities, the agency’s investigators uncovered “insanitary conditions” and positive bacterial test results in “critical drug production areas.”

Contaminated eye drops can easily lead to eye infections and more serious health outcomes.

“These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” said the FDA in their announcement.

So far, there have been no reported adverse events, such as eye infections, associated with the affected products. However, details about the contamination and its cause are still sparse. No strain of bacteria has been specified in the contamination. A representative for the FDA told Healthline that they didn’t have any additional information to share at this time.

Healthline contacted CVS, one of the retailers whose products were affected by the FDA’s alert, and was sent the following response:

“Upon receiving notification by FDA, we’ve immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio. Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter.”

The FDA is encouraging consumers to report any such events through their MedWatch reporting program.

Bacterial outbreaks from contaminated eye drops

The FDA’s warning follows two other similar incidents this year, during which eye drop products were recalled due to contamination.

In August, the agency warned consumers not to purchase and to stop using Dr. Berne’s MSM drops due to the potential of both bacterial and fungal contamination. The manufacturer of those products, Dr. Berne’s Whole Health Products, voluntarily recalled the eye drops. No incidents were subsequently reported to the FDA.

Even more concerning, in February the CDC investigated a multistate outbreak of a drug-resistant bacteria linked to EzriCare Artificial Tears and two other products made by the same manufacturer. As of May 2023, the CDC identified 81 cases of infection of a rare strain of P. aeruginosa across 18 different states associated with use of those products. Among those cases, 14 patients experienced vision loss; four had an eyeball removed; and four deaths occurred.

The FDA said that the products’ manufacturer, India-based Global Pharma, had numerous violations of manufacturing best practices. This included issues with their tamper-evident packaging and insufficient levels of preservatives.

Global Pharma has since voluntarily recalled the products.

Dr. Amesh Adalja, a Senior Scholar at the Johns Hopkins Center for Health Security, and an Adjunct Assistant Professor at the Johns Hopkins Bloomberg School of Public Health, said many types of bacteria can cause eye infections.

“Myriad types of bacteria, when instilled directly into the eyes, have the biological capacity to cause infection,” Adalja said. “Frequent culprits like pseudomonas are more tied to what is most likely to contaminate eye drops rather than some inherent capacity in the bacteria.”

How to identify an eye infection

It is unclear at this time what kind of bacterial contamination is potentially present in these eye drops. However, consumers who believe they may have used or been in contact with them should be aware of the symptoms of eye infection, which can include:

• Discharge from the eye
• Pain or discomfort
• Inflammation
• Redness
• Increased sensitivity to light
• Blurry vision
• Feeling like something is in your eye

“In general, patients should seek medical (which includes optometrist) attention if they have symptoms of an eye infection, especially if they regularly wear contact lenses — which should be removed and not worn in the presence of any infection,” Adalja said.

If you are experiencing symptoms of an eye infection and have used any of the affected products, you should contact your healthcare provider, and the FDA’s MedWatch reporting program.

What you should do

If you think you might have contaminated products in your household, here’s what to do:

• Check the FDA’s full list of affected products in their announcement.
• Discard or dispose of the medications in a safe and sanitary manner. If you need additional guidance, check out the FDA’s guide to safe drug disposal.
• You may be entitled to a refund, so contact the retailer where you bought the product.
• If you’ve used the product, be mindful of any symptoms associated with eye infection like those listed above, and contact your healthcare provider.
• You can also report any symptoms or events to the FDA.

The bottom line

The FDA is warning consumers about the risk of bacterial contamination in 26 over-the-counter eye drop products.

The affected products include brand names from CVS, Rite Aid, and Target, among others.

Consumers should be aware of the symptoms of eye infection if they’ve used any of the listed products and immediately contact their healthcare provider.

The FDA is urging anyone who has purchased the products to immediatly discard or dispose of them.