Which eye drops are recalled? A comprehensive guide for consumers

October 5, 2025 •

4 min read

According to the FDA, dozens of over-the-counter eye drop products were recalled between 2023 and 2025 due to contamination risks and manufacturing violations. This has caused concern among consumers, leading many to ask, which eye drops are recalled?

Quick Summary

A summary of recent eye drop recalls due to contamination and manufacturing issues. Details include FDA warnings, affected products, brand names, and symptoms to watch for. Information on how to identify and safely dispose of recalled products is provided.

Key Points

Check FDA Listings: The US Food and Drug Administration (FDA) is the primary source for current and past eye drop recalls. Regular review of their database is the most reliable way to stay informed.
Common Causes: Eye drop recalls in recent years have been primarily due to potential bacterial contamination, unsanitary manufacturing conditions, and packaging defects that compromise sterility.
Serious Consequences: Contaminated eye drops, such as those from Global Pharma Healthcare recalled in 2023, have been linked to severe infections, vision loss, and in rare cases, death.
Identify Specifics: Recalls often target specific lots or batches. Check your product's NDC (National Drug Code) and expiration date against official recall notices to determine if it is affected.
Stop Use Immediately: If you discover you have a recalled eye drop product, stop using it at once. Seek medical attention if you experience symptoms of an eye infection.
Proper Disposal: Do not simply throw away recalled products. Follow manufacturer or retailer instructions for returns and proper disposal to prevent environmental contamination.
Symptoms to Monitor: Watch for symptoms like eye pain, redness, discharge (yellow, green, or clear), blurry vision, and increased sensitivity to light after using any eye drops.

Navigating the Eye Drop Recall Crisis

In recent years, the market for over-the-counter eye drops has been shaken by numerous product recalls, driven by serious contamination risks and manufacturing concerns. The US Food and Drug Administration (FDA) has worked with manufacturers to pull dangerous products from shelves to protect public health, but many people may still have these items in their medicine cabinets. Knowing the specific products involved, the reasons for their recall, and what steps to take is critical for anyone using eye care products.

Major Eye Drop Recalls from 2023 to 2025

Recent eye drop recalls have involved several different manufacturers and brands, and have been prompted by various issues, including bacterial contamination and non-sterile manufacturing conditions. The most serious incidents were linked to a rare, drug-resistant strain of Pseudomonas aeruginosa, leading to severe eye infections, vision loss, and even death in some cases.

Recalls in 2025

In May 2025, AvKARE voluntarily recalled over 75,000 cases of various eye care products manufactured by BRS Analytical Service due to FDA-identified deviations from Current Good Manufacturing Practice (cGMP) regulations and a lack of sterility assurance. These included Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel and Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution.

Recalls in 2024

In December 2024, Alcon recalled one specific lot (Lot 10101) of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, due to a complaint of fungal contamination. Earlier, in September 2024, Allergan recalled over 3 million tubes of Refresh P.M. and Refresh Lacri-Lube lubricant eye ointments due to a potential tube seal breach that could lead to contamination.

Recalls in 2023

Global Pharma Healthcare issued a widespread recall in February 2023 for EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Eye Ointment due to contamination with a dangerous, antibiotic-resistant strain of Pseudomonas aeruginosa. Multiple over-the-counter artificial tear products manufactured by Kilitch Healthcare India Limited were recalled in October and November 2023 due to unsanitary conditions found at the manufacturing facility. These products were sold under various store brands at major retailers, including CVS and Walmart. Other recalls in 2023 included products from Pharmedica USA (Purely Soothing 15% MSM Drops) and Apotex Corp (Brimonidine Tartrate Ophthalmic Solution) due to sterility concerns or packaging issues.

Comparison of Key Eye Drop Recalls

Understanding the specifics of different recalls can help consumers differentiate between them. The primary reasons often relate to sterility issues, which can manifest differently in terms of severity and root cause. The table below highlights some of the key recent recalls.


Feature	Global Pharma Healthcare (2023)	AvKARE / BRS Analytical Service, LLC (2025)	Kilitch Healthcare India Limited (2023)
Recalled Products	EzriCare Artificial Tears, Delsam Pharma Artificial Tears, Delsam Pharma Artificial Eye Ointment	Artificial Tears, Carboxymethylcellulose Gel/Solution, Lubricant Eye Drops, Polyvinyl Alcohol Ophthalmic Solution	Various store-brand artificial tears sold at retailers like CVS and Walmart
Primary Cause	Potential contamination with antibiotic-resistant Pseudomonas aeruginosa bacteria	FDA-identified manufacturing deviations and lack of sterility assurance	Manufacturing in unsanitary conditions
Health Risk Level	Highest risk, linked to severe infections, vision loss, and death	Class II (remote probability of serious consequences)	Significant risk of eye infections and vision problems
Distribution	Nationwide, sold via online retailers like Walmart and Amazon	Distributed nationwide via AvKARE	Sold nationwide via major retailers and online

What to Do If You Have Recalled Eye Drops

If you discover that a product you own has been recalled, it is crucial to act immediately to protect your health. First and foremost, stop using the product immediately. If you experience any symptoms of an eye infection, such as redness, pain, discharge, or blurry vision, seek medical attention without delay and inform your healthcare provider about the eye drops you have used.

To dispose of the product, do not simply throw it in the trash. The FDA and manufacturers generally advise returning the product to the place of purchase for a refund or following specific disposal instructions provided by the manufacturer. For potentially contaminated products, special handling may be necessary to prevent wider environmental contamination. Consumers can find specific recall announcements and contact information on the FDA's website.

How to Stay Informed

The FDA maintains a comprehensive database of all drug recalls. You can search the FDA's drug recall database using a product's brand name, ingredients, or National Drug Code (NDC). Additionally, signing up for the FDA's safety alerts via email or following their social media accounts can provide timely updates on new and ongoing recalls. When purchasing new over-the-counter eye drops, especially from less familiar brands, it is wise to perform a quick search to ensure the product has a clean safety record.

Conclusion: Prioritizing Ocular Safety

The numerous eye drop recalls in recent years highlight the importance of staying informed and cautious when purchasing and using over-the-counter medications. While these events are relatively rare, the potential consequences, from severe infection to vision loss, are significant. Consumers should immediately stop using any recalled products, seek medical care if experiencing symptoms, and utilize resources like the FDA's website to stay updated on product safety. By taking these proactive steps, you can help ensure the health and safety of your eyes.

Resources

FDA Drug Recalls, Market Withdrawals, & Safety Alerts: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls-market-withdrawals-safety-alerts

Frequently Asked Questions

If you used a recalled eye drop and have no symptoms, stop using it immediately and dispose of it properly. If you experience any symptoms of an eye infection, such as redness, pain, or discharge, seek immediate medical attention and inform your healthcare provider about the recalled product.

You can find the most current and comprehensive list of eye drop recalls by visiting the official US Food and Drug Administration (FDA) website and searching their drug recall database. Health news sites like GoodRx and Drugwatch also maintain detailed lists.

Eye drops are recalled for various reasons, including potential bacterial contamination, non-sterile manufacturing conditions, inadequate preservatives, or packaging defects that could compromise the product's sterility.

While the recalls have involved specific brands and manufacturers (like Global Pharma Healthcare and Kilitch Healthcare India), the affected products were often sold under various retailer brand names, such as CVS and Walmart. It's important to check the specific product information.

You should stop using recalled eye drops immediately. Follow the manufacturer's specific instructions for returns and disposal. Many recommend returning the product for a refund, while some have specific waste management procedures to prevent further contamination.

Symptoms can include blurry vision, eye pain or discomfort, redness of the eye or eyelid, a feeling of something in the eye, and increased sensitivity to light. Discharge that is yellow, green, or clear is also a common sign.

The majority of recent eye drop recalls have targeted over-the-counter products. However, it is always wise to check with your prescribing doctor or pharmacist if you have concerns about any medication, including prescription eye drops.