A Complete Guide to Recent Eye Drop Recalls and Safety

It can be unsettling to hear that common over-the-counter products, especially something as sensitive as eye drops, have been recalled for safety reasons. If you saw news about recalls and are concerned about vision loss or other health risks, you’ve come to the right place for clear, specific information. This guide breaks down exactly which eye drops have been recalled, why they were pulled from shelves, and what steps you should take to protect your health.

The Major Eye Drop Recalls: Brands to Know

Throughout 2023, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued several urgent warnings and recall notices for numerous over-the-counter eye drop products. These recalls happened for different reasons, but the most serious were linked to bacterial contamination that could lead to severe infections, vision loss, and even death.

Here are the specific brands and products at the center of the most critical recalls.

EzriCare and Delsam Pharma Artificial Tears

The most widely reported recall involved EzriCare Artificial Tears and Delsam Pharma Artificial Tears. These preservative-free eye drops, both manufactured by Global Pharma Healthcare, were linked to a widespread outbreak of a rare, drug-resistant strain of bacteria called Pseudomonas aeruginosa.

  • Reason for Recall: Bacterial contamination. The CDC and FDA found that many unopened bottles of these products were contaminated with the dangerous bacteria. Using these contaminated drops could introduce the bacteria directly into the eyes.
  • Associated Risks: The Pseudomonas aeruginosa strain identified in this outbreak was extremely dangerous. It led to dozens of severe infections across multiple states, resulting in hospitalizations, permanent vision loss in several patients, surgical removal of eyeballs in some cases, and even deaths due to the infection spreading to the bloodstream.

The FDA placed the manufacturer on import alert to stop products from entering the country and recommended a complete recall of these products in February 2023.

Apotex and Pharmedica USA Eye Drops

Other recalls followed due to sterility concerns, which means the products may not have been manufactured in a way that guarantees they are free from contamination.

  • Apotex Corporation: Recalled six lots of its Brimonidine Tartrate Ophthalmic Solution, 0.15%. This is a prescription drop used for glaucoma. The recall was issued due to cracks that were found in some of the bottle caps, which could compromise the sterility of the product.
  • Pharmedica USA: Recalled its Purely Soothing, 15% MSM Drops. The recall was initiated because of non-sterility issues, meaning the product could be contaminated with bacteria and pose a risk of eye infection.

The FDA's Broader Warning: Over 25 Products from Major Retailers

In late October 2023, the FDA issued a major consumer warning, urging people to stop using over two dozen different over-the-counter eye drop products. This warning was due to findings of unsanitary conditions at the manufacturing facility and positive bacterial test results from environmental samples.

The FDA recommended the manufacturer recall all lots of these products, which were sold under various store brand names at major national retailers.

Key Retailers and Brands Involved in the October 2023 Warning:

  • CVS Health: Multiple products, including Lubricant Eye Drops and Dry Eye Relief.
  • Rite Aid: Various products like Lubricant Eye Drops, Gentle Lubricating Drops, and Multi-Action Relief Drops.
  • Target: Products sold under the Up&Up brand, including Dry Eye Relief and Extreme Relief drops.
  • Leader (Cardinal Health): Several products including Dry Eye Relief and Eye Irritation Relief.
  • Rugby (Cardinal Health): Lubricating Tears Eye Drops.
  • Velocity Pharma: Lubricant Eye Drop.

The FDA maintains an updated list on its website and has stated it will take action to protect consumers if the manufacturer does not voluntarily recall all affected products.

What Should You Do Now? A Step-by-Step Safety Check

If you use over-the-counter eye drops, it is crucial to check your products immediately. Here are the steps you should take.

1. Check Your Medicine Cabinet Carefully examine any eye drops you own. Look for the specific brands mentioned above:

  • EzriCare Artificial Tears
  • Delsam Pharma Artificial Tears
  • CVS Health brand eye drops
  • Rite Aid brand eye drops
  • Target Up&Up brand eye drops
  • Leader brand eye drops
  • Rugby brand eye drops
  • Purely Soothing 15% MSM Drops

2. Stop Using Recalled Products Immediately If you have any of the products listed in the FDA and CDC warnings, stop using them right away. Continuing to use a potentially contaminated product puts you at serious risk for a dangerous eye infection.

3. Dispose of the Products Safely Do not simply throw the bottles in the trash where they could be found, and do not flush them down the toilet or sink. Follow the FDA’s recommendations for safely disposing of medicine. You can check for local drug take-back programs in your community.

4. Monitor for Symptoms and Contact a Doctor If you have used any of these recalled products, you should be aware of the signs of an eye infection. Contact your doctor or an eye specialist immediately if you experience any of the following symptoms:

  • Blurry vision or vision loss
  • Eye pain or discomfort
  • Redness of the eye or eyelid
  • Feeling like something is in your eye
  • Increased sensitivity to light
  • Yellow, green, or clear discharge from the eye

Early diagnosis and treatment of an eye infection are critical to preventing long-term damage, including permanent vision loss.

Frequently Asked Questions

How do I know if my specific bottle of eye drops is part of a recall? The safest approach is to check the brand name against the FDA’s official recall lists. The FDA website is the best source for the most current information, including specific lot numbers if applicable. When in doubt, it is always safer to stop using the product and purchase a new one from a different, unaffected brand.

Are all store-brand eye drops dangerous? No. The recent warnings were tied to products made by a specific manufacturer. Many other companies produce safe, sterile eye drops for major retailers. However, these events highlight the importance of staying informed about product safety announcements.

What makes a contaminated eye drop so dangerous? The eye is a very sensitive area that can easily absorb bacteria. A non-sterile product can introduce harmful germs directly onto the surface of the eye, leading to infections of the cornea (keratitis) or the interior of the eye (endophthalmitis). These infections can progress rapidly and cause permanent scarring, vision loss, or even require the removal of the eye.