Female puts in eye drops while sitting at a tableShare on Pinterest
The FDA has issued another consumer warning against certain eye drop products. Su Arslanoglu/Getty Images
  • The FDA has announced a voluntary recall for 27 over-the-counter eye drop products.
  • The contaminated products could lead to eye infections, loss of vision, and blindness.
  • Several major retailers’ products have been impacted, including Amazon, CVS, Rite Aid, and Target.
  • The recall is the latest in a series of public health warnings about certain eye drop products and bacterial infection risk.
  • Consumers concerned about eye drop products containing MSM should watch for signs and symptoms of eye infection and seek medical care immediately.

The Food and Drug Administration (FDA) announced an eye drop recall on November 15 due to safety concerns after investigators found unsanitary conditions.

A total of 27 eye drop products are included in the voluntary recall by manufacturing company Kilitch Healthcare India Limited. The recalled eye drop products include all lot numbers and expiration dates.

The products are marketed under the banners of major retailers and brand names including:

  • CVS Health
  • Leader (Cardinal Health)
  • Rugby (Cardinal health)
  • Rite Aid
  • Target Up&Up
  • Velocity Pharma
  • Walmart

The FDA warning also prompted Amazon to stop selling a handful of eye drop products.

The voluntary recall is the latest in a series of FDA warnings about the safety of certain eye drop products.

On October 27, the FDA issued a drug safety alert over certain eye drop products that can potentially cause eye infections, vision loss, and even blindness. Other FDA warnings were issued earlier this spring.

Consumers who have experienced problems that may be related to using recalled eye drop products should contact their physician or healthcare professional.

The FDA urged the eye drop manufacturer Kilitch Healthcare India Limited 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 encourages consumers to report such events through their MedWatch reporting program.

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

On August 22, the FDA issued a warning on eye drops containing the active ingredient methylsulfonylmethane (MSM) due to bacterial or fungal contamination or both.

The FDA states that MSM-containing eye drop products Dr. Berne’s and LightEyez are “unapproved drugs” that are “illegally marketed in the U.S.” The regulators tested the two products and determined they were not sterile.

The FDA states that no adverse events associated with either product were reported at the time of the announcement. However, federal regulators urge people experiencing signs or symptoms of eye infection to talk with their doctor as soon as possible.

In a separate earlier incident, Pharmedica USA issued a voluntary global recall of two lots of its Purely Soothing, 15% MSM eye drops, the FDA announced on March 3.

The recall notice warns consumers that the products being recalled are non-sterile, meaning they may contain bacteria or other germs.

“Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” the warning stated.

Concerned about MSM eye drops?

Consumers with questions concerning MSM-containing eye drops like Purely Soothing can contact Pharmedica by email at osm@pharmedicausa.com or by calling (623) 698-1752 between the hours of 8 a.m. and 5 p.m. Mountain Time.

Was this helpful?

Even more concerning, in February, the CDC investigated a multistate outbreak of 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 using 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 told Healthline in an earlier interview.

“Frequent culprits like pseudomonas are more tied to what is most likely to contaminate eye drops rather than some inherent capacity in the bacteria.”

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

“If someone is experiencing any of these symptoms, no matter how mild, I encourage them to seek medical attention immediately,” said Dr. Diane Hilal-Campo, an ophthalmologist and founder of Twenty / Twenty beauty, in an earlier interview with Healthline.

Adalja added that medical care may include visiting an optometrist, and that contact lenses should be removed and not worn during the presence of any infection.

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

Hilal-Campo recommends choosing artificial tears that come in single-use vials to reduce the risk of infection when soothing your eyes.

“To use correctly, these single-use products should be opened and instilled with clean hands, and then immediately discarded,” she said.

Multi-use bottles increase the risk of spreading bacteria or other germs to the eye, because the dropper tip has more chances to come into contact with the eye, skin, or other surfaces.

Hilal-Campo also suggests that people choose preservative-free eye drops, which she says are easier on the eye’s surface.

In addition, “stick with large, trusted brands for your over-the-counter eyedrops — like Allergan, Alcon, and Bausch and Lomb,” she said.

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 an eye infection like those listed above, and contact your healthcare professional.
  • You can also report any symptoms or events to the FDA.

The FDA announced a voluntary recall about the risk of bacterial contamination in 27 over-the-counter eye drop products.

The affected products included in the recall 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 professional.

The FDA urges anyone who has purchased the products to discard or dispose of them immediately.