After eye drop recall, should consumers be worried about buying over-the-counter drugs?

When Judith Gregory’s left eye became red, teary and painful last year, she made the first of many trips to her eye doctor to deal with complications.

“At that time, I could still see out of my eye,” Gregory said. “A week later, I couldn’t even see out of it.”

The 81-year-old from Elsmere, Kentucky endured a seemingly endless string of medical appointments, surgeries and an eight-day hospital stay stemming from an eye infection. She says the infection was caused by tainted over-the-counter eye drops she purchased at a retail store and online.

Gregory has sued India-based Global Pharma Healthcare, saying its product, EzriCare Artificial Tears, was "contaminated with a dangerous, and potentially life-threatening, bacteria," that caused her "financial and personal injury."

In February, Global Pharma, announced the recall of EzriCare and another eye drop brand it said had potentially been contaminated with drug-resistant bacteria linked to infections that caused deaths, eye-removal surgeries and blindness.

Last month, the U.S. Food and Drug Administration warned consumers to avoid or discard more than two dozen versions of eye drops. The FDA said these over-the-counter products sold or labeled by CVS Health, Rite Aid, Target, Walmart, Leader/Cardinal Health, Rugby/Harvard Drug Group and Velocity Pharma LLC could cause infections leading to vision loss or blindness.

In the latest sweeping public health warning issued on Wednesday, Mumbai-based Kilitch Healthcare India Limited announced a voluntary recall of 27 types of eye drops "due to potential safety concerns" after the FDA. The company's distributor, Velocity Pharma, distributed the eye drops nationwide to wholesalers and retailers such as Target, Rite Aid, CVS and Walmart. See the full list of 27 recalled products here.

The recalls have drawn attention to a problem in plain sight. The over-the-counter eye drops used by millions of Americans for everything from allergies to dry eyes had not been as carefully monitored as prescription products. Doctors say that the vast majority of drops sold without a prescription at chain stores are safe. But not all are: A new scientific paper highlights gaps in the federal oversight of these nonprescription drugs that might have allowed a small number of tainted products to circulate, exposing consumers to serious risk.

In 2022, U.S. consumers purchased 149 million eye care products at a cost of nearly $1.6 billion. Even though millions of consumers use retail eye drops, the market is "largely self-regulated despite these products’ potential for serious injury," according to a viewpoint published this month in the Journal of the American Medical Association Ophthalmology.

Timothy Milton Janetos, an assistant professor of ophthalmology at Northwestern University and co-author of the JAMA Ophthalmology paper, said the vast majority of eye drops sold over-the-counter are safe. He said the challenge for both doctors and consumers is evaluating the less than 1% risk that an eye drop is contaminated.

"It's hard for physicians because we get asked all the time, 'What is safe for me?''' Milton said. "I can't really make a recommendation because there's really no source of information for me to look at and say, 'Oh, this is a good eye drop or a bad eye drop.'"

Milton and his co-author David N. Younessi concluded that "limitations in regulatory oversight highlight a substantial gap in the public health safety net, potentially leaving consumers exposed to harmful products."

Prescription drugs are routinely vetted for safety and efficacy before they get FDA approval, however, over-the-counter drugs don't get a similar review before they land on store shelves.

Over-the-counter drug manufacturers must follow FDA requirements for ingredients, uses, doses, labeling, testing and instructions for administering. Because the agency does not approve these drugs before they are sold on the market, "it is the responsibility of the (drug) manufacturers to follow the guidance ... rather than the FDA to enforce it," the JAMA Ophthalmology paper said.

The paper cited another potential reason contaminated eye drops were allowed to circulate. The FDA suspended most routine, on-site inspections of overseas drug factories during the first two years of the COVID-19 pandemic. Although on-site inspections have resumed, they occur less frequently than they did before the pandemic.

Investigation uncovers blindness, deaths and eyeball removals

Global Pharma Healthcare manufactured three recalled brands: EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma artificial ointment.

The FDA has long faced questions from Congress and oversight investigators about inspections of overseas factories. Before the COVID-19 pandemic, Congress highlighted drug safety issues in the wake of recalls of blood pressure drugs contaminated with small amounts of known carcinogens.

The FDA conducted more than 600 foreign inspections during the two years before the pandemic. From From October 2020 through April 2021, the agency completed 18 "high priority" overseas inspections of factories, mainly in China, according to a 2022 report by the U.S. Government Accountability Office.

The FDA had not inspected Global Pharma's factory in India before the company announced on Feb. 2 the recall of the artificial tears "due to possible contamination." When FDA inspectors arrived for an inspection from Feb. 20 through March 2, the review yielded a 14-page inspection report that listed dozens of safety concerns, including a lack of sterility protocols, airflow concerns and not testing sterility of bottle caps.

The Centers for Disease Control and Prevention joined the investigation, and as of May 15, had tracked 81 people infected with an antibiotic-resistant strain, Pseudomonas aeruginosa. Of those 81 people, 14 were blinded, four had eyeballs surgically removed and four died.

Global Pharma notified the public about the contamination on Feb. 2. However, the CDC's investigation suggests people had been infected months before then. Cases dated back as early as May 2022, according to the CDC.

The CDC's investigation said patients reported using 10 different brands of artificial tears, and some patients had used multiple brands. EzriCare was the only common artificial tears product identified across four health sites reporting clusters of cases. Investigators tested open bottles of EzriCare recovered from patients and discovered the antibiotic-resistant bacteria.

Global Pharma, based in Chennai, India, did not respond to multiple requests for comment.

Gregory, the Kentucky resident who sued Global Pharma, said she purchased EzriCare tears at Walmart and online through Amazon. On June 1, 2022, she told her eye doctor she had eye pain, discharge, redness and blurry vision.

One day later, she was admitted to a hospital intensive care unit where she remained for eight days while she recovered from sepsis, the lawsuit said. Doctors tested her eye and detected the strain of antibiotic-resistant bacteria "consistent with her use of the contaminated product," the lawsuit said.

In addition to Global Pharma, Gregory's lawsuit names EzriCare LLC, Aru Pharma Inc., Amazon and Walmart as defendants.

Regulatory gaps slow recalls, delay removal of potentially harmful products

The CDC has not reported additional cases related to the Global Pharma recall, but since that warning was issued, there have been two more eye drop recalls.

In August, the agency warned consumers to stop using two brands of eye drops due to reports of bacterial contamination.

The most recent warning was issued on Oct. 27 when the FDA advised people to avoid more than two dozen versions of eye drops due to the risk of an infection that could lead to partial vision loss or blindness. The eye drops were sold at major retailers such as CVS, Rite Aid, Target and Walmart.

The FDA said an inspection at an undisclosed manufacturing site revealed unsanitary conditions and positive bacterial tests in drug production areas.

Two of the distributors involved in the recall – Harvard Drug Group and Cardinal Health – said they received the recalled eye drops from a drug supplier called Velocity Pharma LLC. Velocity did not respond to phone messages or emails about the recall.

An FDA spokesman said that drug companies are not obligated to reveal which drugs or drug ingredients are made in which factories. This information is considered confidential commercial information, FDA spokesman Jeremy Kahn told USA TODAY.

Pharmaceutical experts who monitor the drug market say the lack of information about pharmaceutical sourcing can slow recalls and delay the pace of getting potentially harmful products off the market. One large factory might contract with multiple drug companies to supply either finished drugs or drug ingredients. Even drugs sold under different brands might contain the same ingredients or finished drugs from a single factory.

Because such information is considered proprietary, these drug suppliers do not have to disclose this information. The practice is especially common for inexpensive drugs sold over-the-counter, experts say.

"The FDA doesn't have good lists of who's making which (over-the-counter) product for whom," said Erin Fox, senior pharmacy director at University of Utah Health and an expert on drug supply chains. "It just delays recalls and it can delay getting unsafe products off the shelves for consumers."

The FDA acknowledges there are gaps in how it regulates over-the-counter drugs and has said it is seeking to address some blind spots. Among the legislative fixes the agency is pursuing, one is central: It wants the authority to inspect factories that make over-the-counter drugs before the products are sold.

"The FDA believes that ensuring it has an opportunity for an inspection before distribution would help identify potential safety issues related to manufacturing before a drug product could potentially reach patients," Kahn said.

Eye doctors say more should be done

Consumers who experience side effects from eye drops are encouraged to report any adverse events to the drug's manufacturer. Or they can report symptoms directly to the FDA's adverse events database.

Ophthalmologists and their representatives said they view the eye drop recalls as troubling but they praised the FDA's efforts to warn consumers and remove potentially unsafe products from the market.

"More needs to be done to find out what’s causing these problems for over-the-counter eye care products," the American Academy of Ophthalmology, or AAO, said in a statement, adding the organization "is working with stakeholders, including the FDA, to find the causes and explore solutions."

The AAO contends that people should not be afraid to use eye drops but they should ask a pharmacist if the product they want to buy has been recalled.

People who use prescription eye drops should feel at ease to continue using them, the AAO said. None of the existing recalls involve prescription eye drops, the AAO said.

Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at

This article originally appeared on USA TODAY: Eye drop recall stirs concern about over-the-counter drug safety