What Eyedrops Were Recalled? See the Official List

Between 2014 and 2025, at least 110 distinct artificial tear formulations were recalled by the U.S. Food and Drug Administration, with the most high-profile wave triggered by contaminated eyedrops linked to four deaths and a never-before-seen drug-resistant bacterium. The recalled products span dozens of brand names and generic labels, and the FDA’s recall database remains the only comprehensive, continuously updated list. The scope of these recalls, and what caused them, is broader and more alarming than most people realize.

The Outbreak That Brought Eyedrop Safety Into the Spotlight

The recall that made national headlines centered on “Artificial Tears Lubricant Eye Drops” distributed by EzriCare and Delsam Pharma. Between May 2022 and April 2023, four people died of sepsis traced to contaminated bottles of these drops. The infections were caused by a carbapenem-resistant strain of Pseudomonas aeruginosa, a type of bacteria so heavily armed with resistance genes that it had never been reported in the United States before.¹ In February 2023, the FDA and the Centers for Disease Control and Prevention jointly issued a warning and initiated a product recall. But by then, infections had already spread to dozens of patients across multiple states, with some losing an eye or developing bloodstream infections that proved fatal.

The EzriCare and Delsam Pharma products were manufactured by Global Pharma Healthcare in India. What made this outbreak so dangerous was not just the contamination itself but the nature of the organism involved. Genetic testing revealed the bacteria carried the Verona integron-encoded metallo-β-lactamase (VIM) gene, along with other resistance determinants, making them resistant to virtually every standard antibiotic used to treat eye infections.² Whole genome sequencing of isolates from individual patients confirmed that the distinctive resistance profile matched across cases, tying the infections directly to the over-the-counter product.³

How Many Eyedrops Have Actually Been Recalled

The EzriCare/Delsam recall was the most dramatic, but it was far from the only one. A retrospective analysis of FDA recall data identified 110 unique formulations of artificial tears recalled between 2014 and 2025.⁴ That number covers only artificial tears, not the broader universe of prescription eyedrops or other over-the-counter eye products. The vast majority of these recalled products were generic formulations (80 out of 110) and were manufactured in the United States (85 out of 110). The idea that only cheap imports are at risk does not hold up.

The FDA classifies recalls into tiers based on how much danger the product poses. Of the 110 recalled tear formulations, 26 were class I recalls, the most serious category, meaning the product could cause permanent injury or death. Nearly all of those class I recalls (25 of 26) were triggered by confirmed microbial contamination. The remaining 81 were class II recalls, which signal a risk of reversible health problems. Most class II recalls (65 of 81) were issued because manufacturers could not assure sterility, even if no specific organism had been identified in the product.⁴

The FDA maintains a searchable enforcement reports database where you can look up any specific brand or product by name, and that is the only official, continuously updated list. Because recalls happen on a rolling basis and new ones appear without much fanfare, checking the database is more reliable than any snapshot list published in a news article.

Why Sterility Failures Keep Happening

Most people assume that a sealed, commercially packaged eyedrop bottle is sterile. That assumption is reasonable but turns out to be surprisingly fragile. The two main reasons products end up on the recall list are direct microbial contamination (bacteria or fungi already present inside the bottle at the time of sale) and lack of sterility assurance (something went wrong in the manufacturing process that makes it impossible to guarantee the product is clean, even if testing did not find a specific organism).

Lack of sterility assurance accounted for the majority of recalls in the FDA data. This can mean a failure in the facility’s air filtration, problems with the sterilization of filling equipment, deviations from validated manufacturing processes, or inadequate testing before products ship. The result is the same from the consumer’s perspective: you have no way to tell whether the product you just bought is safe.

The over-the-counter eye care market has exploded in recent years. In 2022 alone, sales of OTC eye care products in the U.S. reached about 149 million units, bringing in roughly $1.6 billion in annual revenue.⁵ That market is largely self-regulated. Unlike prescription drugs, which require pre-market approval from the FDA, OTC artificial tears are sold under monographs that set general rules for active ingredients and labeling but do not require the FDA to inspect or approve each individual product before it reaches store shelves. This means problems are often caught only after consumers are harmed.

E-commerce has compounded the problem. Online marketplaces have created new distribution channels where products of uncertain origin can reach consumers quickly, sometimes bypassing the supply-chain checks that traditional brick-and-mortar retailers use.⁶ Buying eyedrops from an unfamiliar third-party seller on an online platform carries more risk than picking them up at a chain pharmacy, though even major retailers have stocked recalled products.

Why the Drug-Resistant Infections Were So Hard to Treat

The Pseudomonas aeruginosa strain from the EzriCare contamination was classified as extensively drug-resistant (XDR), meaning it shrugged off nearly every antibiotic that eye doctors would normally reach for. The standard approach to a bacterial eye infection, antibiotic eyedrops applied frequently, simply did not work. Clinicians treating these patients had to improvise with drugs not normally used for eye infections, often in combinations that had never been studied for this purpose.

Published case reports describe physicians trying topical colistin (an old, toxic antibiotic usually reserved as a last resort), fortified tobramycin delivered via collagen shields soaked in the drug, and combinations of polymyxin B, imipenem-cilastatin, and oral doxycycline. Some infections took close to two months of aggressive treatment to resolve. In at least one published case, a month of combined therapy still had not cleared the infection by the time the study ended.⁷ These were not mild pink-eye cases. Patients experienced corneal ulcers, complete destruction of the eye (panophthalmitis), and systemic bloodstream infections.

Research into new treatments is ongoing. One experimental approach that showed promise in laboratory models of these resistant infections is cefiderocol, a newer antibiotic that works by a different mechanism from the drugs the bacteria had already learned to defeat.⁷ But the broader takeaway for consumers is sobering: if a contaminated eyedrop introduces the wrong organism, the resulting infection can be extremely difficult to cure, even for specialists at major medical centers.

Preservative-Free Drops Are Not Automatically Safer

One of the more counterintuitive findings from the recall data is that preservative-free formulations were recalled at similar rates to preserved ones. Of the 110 recalled products, 62 were preservative-free and 48 contained preservatives, and the difference was not statistically significant.⁴ This runs counter to many consumers’ assumption that preservative-free means purer or cleaner.

The preservatives in conventional multi-dose eyedrops (like benzalkonium chloride) exist precisely to prevent microbial growth after the bottle is opened. Preservative-free formulations skip these chemicals, often because preservatives can irritate the eye over time, especially for people with dry-eye disease who use drops many times a day. But that means the drops have no built-in defense against contamination once the container is opened or if sterility was compromised during manufacturing.

Research confirms this vulnerability. Preservative-free drops in multi-dose containers are at risk of contamination by potentially harmful microorganisms, particularly when the dropper tip contacts the eye or skin.⁸ A study examining contamination based on how people actually use the drops found that nearly half the vials in one group (those used with poor technique, such as touching the dropper tip to the eye) grew bacteria, predominantly Staphylococcus species.⁹ The lesson is practical: preservative-free drops can be the right choice for sensitive eyes, but they demand cleaner handling and ideally should come in single-use vials rather than multi-dose bottles.

How Contamination Builds in Multi-Dose Bottles

Even setting aside manufacturing defects, multi-dose eyedrop bottles accumulate risk the longer they are used. A study of 100 eye medications in clinical use found an overall bacterial contamination rate of about 11 percent, with all contamination found on the dropper tips rather than in the residual liquid inside the bottles.¹⁰ What mattered most was how long the bottle had been open. Bottles used for less than a week had a contamination rate of roughly 3 percent, while bottles used for more than a week jumped to about 24 percent. Bottles used by multiple patients showed the same elevated rate.

This helps explain the general guidance that multi-dose eyedrops should be discarded within a certain window after opening, often 28 days or sooner depending on the manufacturer. It also explains why single-use vials, while more expensive and less convenient, are considered the gold standard for sterility in vulnerable patients like those recovering from eye surgery. If you are using a multi-dose bottle at home, keeping the tip from touching your eye, eyelid, or fingers is the single most effective thing you can do to limit contamination risk.

Warning Signs of a Contaminated Product or Eye Infection

If you have been using an eyedrop product and develop unusual symptoms, it is worth considering whether the drops themselves could be the source. The classic signs of a bacterial eye infection include a thick, purulent (pus-like) discharge, sticky eyelids on waking, redness of the white part of the eye, and a gritty foreign-body sensation.¹¹ Pain, light sensitivity, and worsening vision are more urgent signals that can indicate a corneal ulcer or deeper infection requiring immediate medical attention.

Beyond symptoms, physical signs on the product itself warrant caution. Cloudy or discolored fluid, particles floating in the solution, a broken or missing tamper-evident seal, or an unusual smell are all reasons to stop using a bottle immediately. A bottle that has been stored at high temperatures or in direct sunlight may also have a compromised formulation, even if no bacteria are visible.

You can check whether a specific product has been recalled by searching the FDA’s enforcement reports page at fda.gov. Enter the brand name or manufacturer and look for any matching recall entries. If your product appears, stop using it and follow the instructions in the recall notice, which typically say to dispose of the product. If you have already experienced symptoms, bring the bottle (or a photo of the label) to your eye care provider so they can report it and, if necessary, send cultures that help identify the organism involved.

What Has Changed Since the EzriCare Outbreak

The 2023 outbreak prompted increased FDA scrutiny of the OTC eyedrop market. The agency issued warning letters to manufacturers, increased inspections of production facilities, and took action against specific companies whose manufacturing practices were found to be deficient. Several additional brands were recalled in the months following the initial EzriCare notice, some from entirely different manufacturers, as the FDA broadened its surveillance.

Advocacy organizations and professional groups have also pushed for tighter standards. Proposals include requiring pre-market testing or notification for OTC eye products, mandating specific bottle-design features that reduce contamination risk (such as anti-touch tips or single-use packaging), and strengthening import controls on products manufactured overseas.¹² Whether these proposals will translate into binding regulatory changes remains uncertain. The OTC monograph system has been in place for decades, and changing it requires legislative or rulemaking action that moves slowly.

For now, the practical reality is that consumers bear much of the responsibility for checking recalls, handling products carefully, and recognizing when something has gone wrong. The market for artificial tears is enormous and growing, driven in part by increased screen time and a rising prevalence of dry-eye disease. That combination of high demand, low regulatory barriers, and an expanding patchwork of online sellers means the conditions that produced the 2023 outbreak have not fundamentally changed.

Practical Steps for Choosing and Using Eyedrops Safely

Given how the recall landscape looks, a few straightforward habits reduce your risk meaningfully:

Check the FDA database: Before using a new product, especially an unfamiliar brand, search the FDA’s enforcement reports for any recall history tied to that product or manufacturer.
Buy from established retailers: Products purchased through major pharmacy chains or their verified online storefronts are more likely to have passed through proper supply-chain oversight than those from third-party marketplace sellers.
Prefer single-use vials when practical: Single-use packaging eliminates the contamination that accumulates in multi-dose bottles over time. If you use drops frequently, the added cost may be worth it.
Never touch the dropper tip: Keep it away from your eye, eyelids, fingers, and any surface. This is the single biggest controllable risk factor for introducing bacteria into the bottle.
Discard open bottles on schedule: Follow the manufacturer’s guidance for how long a multi-dose bottle can be used after opening. If no guidance is given, a common benchmark is 28 days.
Store properly: Keep drops at room temperature, out of direct sunlight, and away from humid environments like bathrooms.

None of these steps would have helped with the EzriCare situation, where bacteria were in the bottles before consumers ever opened them. That kind of manufacturing contamination is beyond individual control. But the majority of eyedrop-related infections are acquired after purchase, through poor handling or prolonged use, and those are risks you can manage.

How Eye Infections From Contaminated Drops Differ From Ordinary Pink Eye

A common misconception is that an eye infection from contaminated drops looks and acts like typical conjunctivitis. In mild cases, the early symptoms can be similar: redness, discharge, discomfort. But infections caused by organisms like drug-resistant Pseudomonas progress faster and cause far more damage. Corneal ulcers can develop within days, and the infection can penetrate deeper layers of the eye, leading to endophthalmitis (infection inside the eyeball) or even panophthalmitis (destruction of all eye structures). Some patients in the EzriCare outbreak required surgical removal of the affected eye.¹

The infections also did not stay confined to the eye. Four patients developed bloodstream infections and died of sepsis, meaning the bacteria entered the circulatory system and caused organ failure.¹ This is rare with typical conjunctivitis-causing organisms but becomes a real threat when the infecting bacterium is resistant to standard antibiotics and the patient has any underlying vulnerability, such as older age, a weakened immune system, or recent eye surgery. The difference between garden-variety pink eye and a drug-resistant infection from a contaminated product is the difference between a nuisance and a medical emergency.

1
Ophthalmology. Infections from Over-the-Counter Artificial Tears: Implications for Patients and Clinicians
2
PubMed Central. Extensively drug-resistant Pseudomonas aeruginosa panophthalmitis from contaminated artificial tears
3
PubMed Central. Investigating and Treating a Corneal Ulcer Due to Extensively Drug-Resistant Pseudomonas aeruginosa
4
PubMed Central. Retrospective analysis of U.S. Food and Drug Administration recalls of artificial tear solutions from 2014 to 2025
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JAMA Network. Regulatory and Informational Gaps in the Over-the-Counter Eye Care Product Industry—Over the Counter, Under the Radar
6
PubMed. OTC: Over the Counter, or Open to Contamination? A Review of Over-the-Counter Lubricating Eye Drops Safety
7
Ophthalmology Science. Cefiderocol Is an Effective Topical Monotherapy for Experimental Extensively Drug-Resistant Pseudomonas aeruginosa Keratitis
8
PubMed Central. Microbial contamination of preservative free eye drops in multiple application containers
9
PubMed Central. Microbial Contamination of Preservative-Free Artificial Tears Based on Instillation Techniques
10
PubMed Central. Bacterial Contamination of Multi-dose Eye Drops at Ophthalmology Department, University of Gondar, Northwest Ethiopia
11
Recent Patents on Inflammation & Allergy Drug Discovery. Bacterial Conjunctivitis in Childhood: Etiology, Clinical Manifestations, Diagnosis, and Management
12
Eye & Contact Lens. OTC: Over the Counter, or Open to Contamination? A Review of Over-the-Counter Lubricating Eye Drops Safety