Health and Me

Rachel V Thomas

Over 3 Million Eye Drops Recalled By US FDA Over Sterility Concerns: Know How To Stay Safe

Over 3 Million Eye Drops Recalled By US FDA Over Sterility Concerns: Know How to Stay Safe

More than 3 million eye drops have been recalled by the US Food and Drug Administration (FDA) over sterility concerns. 

The FDA, in its Enforcement Reports, stated that the products recalled “lack assurance of sterility.” 

While so far, there are no reports of injuries associated with the eye drops, the FDA notice classified the action as a “Class II recall.” 

Class II recalls apply to products that can cause “temporary or medically reversible” health problems. 

The 3,111,072 products were manufactured by California-based K C Pharmaceuticals and were sold under names such as “Dry Eye Relief Eye Drops,” “Sterile Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops,” according to the FDA notice. 

California-based K C Pharmaceuticals made the voluntary recall of the eye drops in early March. 

The eight types of <span>eye drop</span> products were sold at major retailers, including CVS, Walgreens, and Rite Aid. They have expiration dates ranging from April to October. 

<h2><span rel="noindex">Eye Drop Recall</span>: Implications For Patients </h2>

“The recall is very large, potentially affecting over a million people,” said C. Michael White, clinical pharmacologist and pharmacist at the University of Connecticut, in a Commentary published in The Conversation. 

He added that “using <span>nonsterile eye drops</span> that harbor bacteria and fungus can cause <span>eye infections</span>, which can become severe because the immune system has a hard time accessing the eyeball and fighting the microbes”. 

However, other experts stated that infections from eye drops are rare. Notably, the current voluntary recall has not reported any infections to date. 

According to Jeffrey H. Ma, an ophthalmologist at the University of California-Davis Health, people with dry eyes must use preservative-free drops that come in disposable single-use vials. He advised people to dispose of any eye drops included in the recall.

“Drops that are not on the recall list should be safe to use,” said Ma. “If you have any of the drops on the list, you should immediately throw them away.”

<h2>How To Avoid Common Eye Infections </h2>

Beyond contaminated eye drops, several common eye infections can be triggered by environmental factors such as sun exposure, dust, and dirt—especially among people who work outdoors or spend long hours in front of screens.

“Conjunctivitis, known as pink eye, is the most common type of eye infection,” Ma said. Pink eye is estimated to affect about six million people every year.

“It is usually viral or bacterial, and is transmitted through direct contact, such as touching or rubbing your eyes after touching a contaminated item,” Ma added.

Contact lens wearers also have a higher risk of eye infections, particularly if they sleep in their lenses.

<ul><li>blurry vision </li><li>discharge </li><li>pain or discomfort </li><li>redness of the eyelid or eye </li><li>feeling like there is something in the eye </li><li>increased sensitivity to light</li></ul> 

Experts urged investing in good sunglasses with ultraviolet protection and maintaining proper hygiene, such as washing hands before touching the lenses. 

"For those who are using computers a lot, you need to blink your eyes constantly, take breaks in between, and drink a lot of water. Dehydration is also a contributing factor to dry eye," Dr Anita Sethi, who is Principal Director and HOD Ophthalmology, Max Multi Specialty Centre at Panchsheel Park.

She also recommends using zero-number protective glasses and computer glasses that can decrease strain and dry eye. 

While advising people to stay away from natural remedies like turmeric or ginger put inside the eye, Dr Sethi urged people to consume more “foods rich in vitamin E, antioxidants” to maintain eye health.

Health Conditions A-Z

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Eye Drop Recall

FDA eye drop recall

eye drop

nonsterile eye drops

Artificial Tears

Eye Infections

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More than 3 million eye drops have been recalled by the US Food and Drug Administration (FDA) over sterility concerns. The FDA, in its Enforcement Reports, stated that the products recalled “lack assurance of sterility.”  While so far, there are no reports of injuries associated with the eye drops, the FDA notice classified the action as a “Class II recall.” Class II recalls apply to products that can cause “temporary or medically reversible” health problems.  The 3,111,072 products were manufactured by California-based K C Pharmaceuticals and were sold under names such as “Dry Eye Relief Eye Drops,” “Sterile Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops,” according to the FDA notice.  California-based K C Pharmaceuticals made the voluntary recall of the eye drops in early March.  The eight types of eye drop products were sold at major retailers, including CVS, Walgreens, and Rite Aid. They have expiration dates ranging from April to October.  Eye Drop Recall: Implications For Patients “The recall is very large, potentially affecting over a million people,” said C. Michael White, clinical pharmacologist and pharmacist at the University of Connecticut, in a Commentary published in The Conversation. He added that “using nonsterile eye drops that harbor bacteria and fungus can cause eye infections, which can become severe because the immune system has a hard time accessing the eyeball and fighting the microbes”. However, other experts stated that infections from eye drops are rare. Notably, the current voluntary recall has not reported any infections to date.  According to Jeffrey H. Ma, an ophthalmologist at the University of California-Davis Health, people with dry eyes must use preservative-free drops that come in disposable single-use vials. He advised people to dispose of any eye drops included in the recall. “Drops that are not on the recall list should be safe to use,” said Ma. “If you have any of the drops on the list, you should immediately throw them away.” How To Avoid Common Eye Infections  Beyond contaminated eye drops, several common eye infections can be triggered by environmental factors such as sun exposure, dust, and dirt—especially among people who work outdoors or spend long hours in front of screens. “Conjunctivitis, known as pink eye, is the most common type of eye infection,” Ma said. Pink eye is estimated to affect about six million people every year. “It is usually viral or bacterial, and is transmitted through direct contact, such as touching or rubbing your eyes after touching a contaminated item,” Ma added. Contact lens wearers also have a higher risk of eye infections, particularly if they sleep in their lenses. Symptoms of an eye infection include: blurry vision discharge pain or discomfort redness of the eyelid or eye feeling like there is something in the eye increased sensitivity to light Experts urged investing in good sunglasses with ultraviolet protection and maintaining proper hygiene, such as washing hands before touching the lenses. "For those who are using computers a lot, you need to blink your eyes constantly, take breaks in between, and drink a lot of water. Dehydration is also a contributing factor to dry eye," Dr Anita Sethi, who is Principal Director and HOD Ophthalmology, Max Multi Specialty Centre at Panchsheel Park. She also recommends using zero-number protective glasses and computer glasses that can decrease strain and dry eye.  While advising people to stay away from natural remedies like turmeric or ginger put inside the eye, Dr Sethi urged people to consume more “foods rich in vitamin E, antioxidants” to maintain eye health.