More than 1.8 million cartons of eye drops have been recalled nationwide due to manufacturing issues that may have made the products unsterile.
AvKARE and the FDA issued recall notices without detailing the specific issue or health risks associated with the eye drops.
But they state that improper manufacturing resulted in a ‘lack of assurance of sterility’ and ‘may lead to products of unacceptable quality.’
‘It is not possible to rule out patient risks resulting from use of these products,’ the AvKARE notice states.
Using eye drops that are not properly sterilized can lead to serious eye infections, potentially causing temporary vision loss or even blindness.
In 2023, the CDC identified 50 infections across 11 states that stemmed from contaminated eye drops containing antibiotic-resistant bacteria. The outbreak resulted in one fatality and several individuals suffering permanent blindness.
The recalled products named in the notice are: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution.
The faulty drops were distributed between May 26, 2023 and April 21, 2025, and all of them appear to be for alleviating dry eye symptoms.
More than 1.8 million cartons of eyedrops have been recalled due to manufacturing issues that may have made them unsterile
The FDA discovered the manufacturing issues during an audit. Their notice does not state who manufactured the drops or if they were made by a particular brand.
AvKARE, a healthcare distributor for pharmaceuticals and infection control products based in Pulaski, Tennessee, urged consumers who purchased the potentially contaminated drops to stop using them immediately.
It also stated that stores which purchased the drops should remove them from their inventory and return them to AvKARE for a full refund, which will also cover the cost of shipping them back to the distributor.
‘We regret any inconvenience that this may cause,’ the notice states.
It also explains that BRS Analytical Service, LLC. notified AvKARE of the voluntary recall.
BRS Analytical Service is an independent contract testing laboratory that tests pharmaceutical products to make sure they are properly manufactured and ready for distribution.
The recalled eye drops were intended to treat dry eye, which is a condition that occurs when the eyes either don’t produce enough tears to keep the eye moist, or the tears they produce don’t work properly.
Symptoms include irritation that feels like a gritty or sandy sensation in the eyes, stinking or burning; redness; sensitivity to light; stringy mucus in or around the eyes; blurred vision and tired eyes.
This recall comes at a time when more people may be using eye drops, as allergy season can make dry eye symptoms worse.
Using eye drops that are not properly sterilized can lead to serious eye infections, potentially causing temporary vision loss or even blindness
Allergic reactions to pollen cause inflammation in the eyes, which can reduce tear production.
Allergy medications such as antihistamines or decongestants can contribute to dry eye symptoms too.
As a result, eyedrop sales tend to increase in the spring, when the pollen count is high.
This is a Class II recall, which means use of or exposure to these drops may cause temporary or reversible health issues, but the likelihood of serious health consequences is low, according to the FDA.
At this time, it does not appear that any consumers have reported health issues related to the use of these eye drops.
