Retrospective analysis of U.S. Food and Drug Administration recalls of artificial tear solutions from 2014 to 2025

Most formulations of recalled tears were generics recalled because of lack of sterility assurance. Overall, recalls tied to confirmed microbial contamination of tears remain rare compared with their prolific use.

Abstract

Purpose:

To examine all recalls of artificial tears from 2014 to 2025 to identify the most common types, classes of products, and associated reasons for recalls, and to provide guidance on safety.

Setting:

United States.

Design:

Retrospective epidemiologic assessment.

Methods:

Artificial tear recalls from January 2014 to August 2025 were identified through the U.S. Food and Drug Administration Enforcement Report. Data on country of manufacture, classification, ingredients, preservative use, and recall reason were analyzed. The primary end points of the study were the most common causes of recall, and the types of products associated with each recall. Secondary end points included classification of recall reasons, common ingredients associated with recalls, and the country where the product was manufactured.

Results:

110 unique formulations of recalled tears were identified. Most recalls were class II (81) linked to lack of assurance of sterility (65) that could cause reversible adverse health outcomes and class I (26) due to microbial contamination (25) that could cause permanent adverse outcomes. Preserved (48) and preservative-free tears (62) were similarly implicated (χ²(3, N = 110) = 6.71, P = .082). Most recalled tears were manufactured in the United States (85) and were generic formulations (80).

Conclusions:

Most recalled tears were U.S. generics recalled because of lack of sterility. Preservative-free and preserved tears had similar recalls. Overall, recalls tied to confirmed microbial contamination of tears remain rare compared with their prolific use in the U.S.

Drug recalls are an important safety concern for patients and clinicians. In February 2023, the Centers for Disease Control and Prevention (CDC) reported a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa that was associated with eye infections after artificial tear usage.¹ To the authors' knowledge, this strain of pseudomonas, a carbapenem-resistant Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase, had never been reported in the United States before.² EziCare Artificial Tears, a preservative-free, over the counter (OTC) product packaged in multidose bottles was reported as the most common product used by all affected patients.^2,3 Over the course of the investigation, 81 patients were identified as having an eyedrop-associated pseudomonas infection from 18 states.¹ These infections included keratitis, endophthalmitis, panophthalmitis, and other unspecified eye infections. Four of these patients died within 30 days of having their culture collected, 11 became legally blind, 4 patients required globe removal, and 3 patients had moderate visual impairment.¹ The culprit, EziCare artificial tears, was linked to the Global Pharma Healthcare facility in Chennai, India, and after this, Global Pharma voluntarily recalled 3 products: EziCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Ointment.^2,4,5 However, over the course of 2023 to 2024, the U.S. Food and Drug Administration (FDA) recalled 42 additional artificial tear formulations because of sterility concerns, spurring wide-spread concern around the safety of these products.⁶

Dry eye disease (DED) is estimated to affect more than 16 million people in the U.S., and its prevalence is growing over time.⁷ Artificial tears are commonly used to manage DED, and their ease of use and OTC accessibility often make them a first-line treatment option.^8,9 Systematic reviews have shown that regular use of artificial tears can improve DED symptoms such as pain, ocular dryness, foreign burning sensation, and photophobia.^9,10 In 2024, an estimated 123.35 million Americans used artificial tears.¹¹ Some artificial tears contain preservatives to protect against microbial growth during storage and repeated use once the bottle has been opened.¹² However, these can have adverse side effects if used for an extended period, such as inflammation, foreign body sensations, and vision deterioration.⁸ Thus, preservative-free tears, commonly provided in single-dose units, are recommended for long-term artificial tear users.⁸ Although both products are generally considered to have a low-risk profile, eyedrops need to be sterile.^8,9 As OTC products, they have been historically underinspected by the FDA.^6,13

The FDA defines recalls as methods to remove or correct products that are in violation of FDA laws and may be subject to legal action. Recalls can be undertaken at the request of the FDA, under FDA order under statutory authority, or at any time by manufacturers, to protect the public from products that may cause injury or may be defective or deceptive.¹⁴ Recalled products are identified through a combination of manufacturing inspections, company self-reporting, routine monitoring of manufacturing/labeling compliance, adverse event surveillance, sampled sterility testing, and consumer and healthcare provider complaints.^15,16 Adverse events related to products can be reported by consumers or health professionals to the FDA Adverse Event Reporting System.¹⁶ The FDA can work with the CDC to investigate emerging patterns based on health reports and issue recalls as needed. Alternatively, companies can self-report safety or efficacy issues with their products to the FDA to avoid mandatory product removal from the market. The FDA classifies drug recalls into 3 categories based on severity.¹⁷ Class I recalls are for products whose use can cause serious adverse health consequences, including death. Class II recalls are for products that can cause temporary or reversible adverse health outcomes. Class III recalls are unlikely to cause adverse health outcomes. The number of recalls has been increasing in recent years which has been attributed to increasing regulation by the FDA in an increasingly international pharmaceutical market.^18,19

The widespread recalls of artificial tears and their associated media coverage led to increasing fear among patients about the use of tears for DED and doctor uncertainty about their recommendation.^20–23 This study aims to do a regulatory analysis of the FDA recalls of artificial tears over the past 10 years to identify the common causes, trends, and types of artificial tears behind the recalls and thus have a better understanding of safety.

METHODS

This study was a retrospective data analysis evaluating FDA recalls of artificial tear solutions from 2014 to 2025. Data for FDA-issued recalls for ophthalmic solutions were imported from the FDA Enforcement reports (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports) in a downloadable CSV formatted file. Keywords of “artificial tears,” “eyedrops,” “ophthalmic solution,” “eye gel,” and “eye ointment” were used in the “Product Description,” and “Drugs” were set as the product type to identify relevant products. Date ranges were set from January 1, 2014, to August 11, 2025. To identify artificial tears from the extracted files, the investigators used the information provided in the product descriptions and the product ingredient list obtained through its universal product code, in combination with clinical knowledge. All products other than artificial tears, for example, allergy drops, redness relief drops, pink eye products, and eye washes, were excluded from this analysis. Furthermore, products that were identical in preparation and formulation (lubricant eyedrops, eye gels, and ointments) but differed in quantity were excluded, that is, if the same product formulation was sold but in packs of 2 and packs of 4, only 1 line item was included for analysis. The universal product codes were also used to classify artificial tears as preservative-free vs. preservative containing. The type of product (branded vs generic) was identified by reviewing available information on the company website around the marketing of the product.

The following data were analyzed: country where product was manufactured, recall classification (I, II, or III), use of preservatives (yes/no), type of product (branded/generic), product ingredients, reason for recall, and recall year. Recalls were sorted by reporting date to identify potential correlations by year. To decrease the number of reasons associated with recalls due to duplication, the rationale for the recall was reclassified to one of the following categories: lack of assurance of sterility, confirmed nonsterility/microbial contamination, mislabeling, common good manufacturing practice deviations, out of specification, and presence of particulate matter. Recalls that classified for more than 1 category were classified by the authors based on the most clinically significant reason. Definitions for these classifications are listed in Table 1. All classifications were conducted by A.B. and double-checked for accuracy by P.C.K.

Table 1.

Definitions of reasons for drug recalls

Reason	Definition
Lack of assurance of sterility	Suspected contamination of a product by another substance or microbe based on FDA inspection of unopened products or manufacturing conditions
Confirmed nonsterility/microbial contamination	Confirmed contamination of the product by a substance or microbe on FDA sampling of unopened products or analysis of manufacturing conditions
Mislabeling	Incorrect or missing information on a product label or use of an ingredient not mentioned on a label
Common good manufacturing deviation	Deviations from set manufacturing standards, for example, improper storage conditions due to temperature abuse or warehouse not following current good manufacturing practices, defective delivery due to damage to the container
Out of specification	Failed uniformity specifications due to wrong color, viscosity, pH; failed stability tests; crystallization or failed dissolution of particulates
Presence of particulate matter	Consumer reported complaints of observing particulates in products

The primary end points of the study were the most common causes of recall and the types of products associated with each recall. Secondary end points included classification of recall reasons, common ingredients associated with recalls, and the country where the product was manufactured. Descriptive statistics were used to quantify these categories, and frequency tables were cross tabulated using Microsoft Excel (2018). Pearson chi squared tests were performed using StataMP (v. 18.5, Statacorp LLC).

The data used for this analysis were extracted from a public repository and will be made available upon request.

RESULTS

From January 1, 2014, to August 11, 2025, our search criteria identified a total of 286 ophthalmic products recalled by the FDA. Of these, 121 (42.3%) were identified as OTC artificial tears. These comprised of 110 unique formulations that were included in this study. All recalls were voluntary and company initiated. Most tears were classified under class II recalls (81 formulations, 73.6%) followed by class I (26 formulations, 23.6%). Most of the recalled tears were manufactured in the U.S. (78, 77.3%) followed by India (21, 19.1%) and Jordan (4, 3.6%). Preserved tears made up 56.4% (62 formulations) of the recalls, while 43.6% (48 formulations) were preservative free. Most of the recalled tears were generics (80 formulations, 72.7%) (Table 2).

Table 2.

Characteristics of artificial tear recalls (N = 110 formulations) from 2014 to 2025^a

Characteristic	No. of recalls (%)
Recall year
2014	1
2015	2
2016	2
2017	1
2018	2
2019	46
2020	1
2021	2
2022	5
2023	31
2024	14
2025a	4
Country of origin
U.S.	85 (77.3)
India	21 (19.1)
Jordan	4 (3.6)
Recall classification
Class I	26 (23.6)
Class II	81 (73.6)
Class III	3 (2.8)
Product type
Branded	30 (27.3)
Generic	80 (72.7)
Use of preservatives
Preservative-free tears	48 (43.6)
Preserved tears	62 (56.4)

^aData extracted until August 11, 2025

The most common cause of recalls was lack of assurance of sterility (66), followed by confirmed nonsterility (28) and common good manufacturing deviations (7). Class I recalls were mainly mapped to confirmed microbial contamination (25 of 26 formulations), while class II recalls were principally associated with lack of sterility assurance (65 of 81 formulations) (Table 3). To avoid issues with smaller cell sizes and improve statistical power, recalls reasons of out of specification, presence of particulate matter, and mislabeling were grouped “other.” The chi square test of independence showed a significant association between the classification and reason for recall, χ²(6, N = 110) = 123.48, P < .001.

Table 3.

FDA's recall reasons and their associated classification

Recall reason	No. of recalls
	Class I (n = 26)	Class II (n = 81)	Class III (n = 3)	Total (n = 110)
Lack of assurance of sterility	1	65	—	66
Microbial contamination	25	3	—	28
Common good manufacturing deviations	—	7	—	7
Other
Mislabeling	—	2	3	5
Out of specification	—	1	—	1
Presence of particulate matter	—	3	—	3

The highest number of tear recalls occurred in 2019 (46) followed by 2023 (31) and 2024 (14) (Table 4). Recalls of preservative-free tears were primarily attributed to lack of assurance of sterility (35 of 48 formulations). For preserved tears, recalls were attributed to confirmed microbial contamination (21) in addition to lack of assurance of sterility (31). Overall, preservative-free tears were recalled more often because of lack of assurance of sterility than microbial contamination, compared with preserved tears. However, the chi square test of independence showed no significant association between the use of preservatives and reason for recall, χ²(3, N = 110) = 6.71, P = .082.

Table 4.

Recalls reasons and their association with other characteristics

Characteristics	Recall reason
	Lack of sterility assurance	Microbial contamination	cGMP deviation	Other
				Mislabeling	OOS	PPM
Preservative use
Preservative-free tears (n = 48)	35	7	3	1	—	2
Preserved tears (n = 62)	31	21	4	4	1	1
Product type
Branded (n = 30)	13	10	3	2	—	2
Generic (n = 80)	53	18	4	3	1	1
Country of origin
U.S. (n = 85)	59	10	7	5	1	3
India (n = 21)	3	18	—	—	—	—
Jordan (n = 4)	4	—	—	—	—	—
Recall years
2014-2018 (n = 7)	2	—	—	2	—	3
2019 (n = 46)	45	—	—	—	1	—
2020-2021 (n = 3)	1	1	—	1	—	—
2022 (n = 5)	—	—	5	—	—	—
2023 (n = 31)	4	25	2	—	—	—
2024 (n = 14)	10	2	—	2	—	—
2025 (n = 4)a	4	—	—	—	—	—

cGMP = common good manufacturing; OOS = out of specification; PPM = presence of particulate matter

^aData extracted until August 11, 2025

Recalls of generic tears were associated with lack of sterility assurance (53) and microbial contamination (18), while recalls of branded tears were mainly associated with lack of sterility assurance (13). The chi square test of independence showed no significant association between product type and reason for recall, χ²(3, N = 110) = 5.11, P = .164.

A review of the ingredients in preserved tears revealed that the most commonly used tear preservatives were benzalkonium chloride, sodium perborate, polyquad, and purite (stabilized oxychloro complex). The mechanism of action of these preservatives has been studied previously.¹² Across preserved and preservative-free tears, the most common active ingredients were carboxymethylcellulose sodium solution, propylene glycol and/or polyethylene glycol, mineral oil, and white petroleum. One ingredient common across preservative-free and preserved eyedrops was a low concentration of sodium chloride.

DISCUSSION

The widespread and consecutive nature of FDA's recalls of eyedrops in 2023 to 2024 spurred fear and uncertainty about the use of artificial tears for DED.^20,22,24,25 To the authors' knowledge, although other reports have examined the role of the FDA in OTC recalls and implications for patients and providers based on the recalls, this study is the first of its kind to identify trends in the FDA's artificial tear recalls over the past 10 years.^6,26

The number of artificial tear recalls has hovered around 1 to 5 formulations per year except for 2019 and 2023 to 2024 which were outliers (Table 2). Although the highest number of tear recalls occurred in 2019, most (43 of 45 recalls) were attributed to manufacturing sterility concerns at 1 organization—Altaire Pharmaceuticals.^27,28 As the organization voluntarily recalled the affected products and reported no associated adverse events, this recall did not garner much publicity.^27,28 The 2023 to 2024 artificial tear recalls were unique in that they involved 13 different organizations across 3 countries and had associated adverse events.² The 2023 to 224 recalls were spurred by an FDA investigation of an outbreak of drug-resistant eye infections that were mapped to 3 generic eyedrops manufactured in India.⁶ Since then, the FDA increased surveillance of other OTC eyedrop manufacturers, finding additional sterility concerns which triggered the wave of subsequent recalls. The most concerning manufacturing violations were found at a factory in Mumbai, India, that suggested an ongoing concern with nonsterile manufacturing conditions.²⁹ This resulted in 15 formulations being removed from the market including products sold at CVS, Target, RiteAid, and Walmart.⁵ Other inspections in the U.S. also revealed other sterility violations that led to further recalls. It is important to note that these facilities may have been substandard for some time and were only bought to light when the FDA decided to inspect them.

We found that suspected or confirmed contamination of artificial tears was the biggest cause of recalls suggesting that maintaining sterility is a challenge in the production and distribution of artificial tears.¹⁶ In addition, most of these recalls were attributed to tears manufactured within the U.S. As drug manufacturing has become increasingly international, with India and China comprising one-third of foreign drug establishments that supply the U.S., the FDA inspection process has been challenged by travel, resources, and language barriers.^6,30,31 This may contribute to the higher incidence of recalls from U.S. facilities that are surveilled more frequently than international ones.³¹ We also note that the number of confirmed cases of microbial contamination was higher in nondomestic facilities (e.g., 18 of 21 products from India) than in the U.S. (10 of 85 products).

Regarding the types of products, we found that preservative-free (48) and preserved tears (62) had similar recalls. Generally, preservatives are added to multidose containers to reduce microbial activity during storage, repeated usage, and instances of contamination. Thus, there tends to be greater concern around the sterility of preservative-free tears. However, we found no significant difference between the use of preservatives in artificial tears and their reasons for recalls. The comparable number of recalls may also suggest that both types of tears have similar risk profiles. In addition, we note that generic brands of artificial tears were recalled at higher numbers than branded formulations. This is although both types of OTC tear formulations are held to the same FDA manufacturing standards. Although this may be partly attributed to the greater number of generics compared with branded counterparts, further research is needed to investigate concerns around the safety of generics.^32,33

Finally, we note that a low concentration of sodium chloride (NaCl) is a common ingredient across all types of recalled tears. This key ingredient is used to mimic the natural electrolyte balance of human tears to improve the osmotic balance of the ocular surface and maintain tear film stability.³⁴ However, there is emerging evidence from food studies that low NaCl concentrations can have enhancing effects on microbial growth.³⁵ This may be attributed to a variety of pathways including increased regulation of microbial osmotic pressure or enhanced activity of certain microbial enzymes.³⁶ Thus, further research may be needed to examine its role in the contamination of ophthalmic products.

This study has several limitations. First, our data were pulled from the FDA website using limited keywords. We believe our search to be comprehensive, yet there may be recalls that were not captured in our dataset. Second, our analysis only looked at artificial tears, and other OTC eyedrops such as those for allergies or redness relieve were excluded from the analysis. Thus, we cannot extrapolate our findings to all OTC eye products. Finally, our conclusions were based mainly on an analysis of recalls rather than their associated adverse events which was not provided by this dataset. Therefore, our conclusions are limited to data on tears recalled for any reason including those not related to safety, for example, mislabeling. In summary, this study showed that the number of artificial tear recalls remains low compared with their prolific use in the U.S., suggesting that these have a low risk profile and can be used safely.¹¹

WHAT WAS KNOWN

• The U.S. Food and Drug Administration's (FDA) ongoing recall of artificial tears between 2023 and 2025 was widely covered in mass media and led to patient and physician concern over the safety of this common over the counter product.

• To date, to the authors' knowledge, no one has looked at a historical analysis of the FDA's artificial tear recalls to identify any trends and commonalties of these recalls and provide some guidance on its safety going forward.

WHAT THIS PAPER ADDS

• All artificial tear recalls over the last decade were analyzed to identify trends in the recall classification, recall reasons, and types of artificial tears recalled by the FDA.

• It was found that most recalled tears were generics manufactured in the U.S. Overall, recalls tied to confirmed microbial contamination of these products remain rare compared with their prolific use in the U.S.