More than 1.8 million cartons of eye drops sold across the US have been recalled due to quality concerns. Five products are affected following an audit by the US government’s Food and Drug Administration (FDA).
A pharmaceutical distribution company has told consumers to stop using the eye care products immediately. AvKARE said BRS Analytical Service, LLC is initiating a voluntary recall due to “manufacturing cGMP (Current Good Manufacturing Practice) deviations”. It said health hazards are unknown, but the deviations “may lead to products of unacceptable quality”.
“It is not possible to rule out patient risks resulting from use of these products,” the notice said.
It added: “This recall is being carried out with the knowledge of the US Food and Drug Administration. Further use of this product should immediately cease.”
The solutions being recalled are: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution and Polyvinyl Alcohol Ophthalmic Solution.
The solutions were shipped between May 26 2023 and April 21 2025, according to the press release by AvKARE titled ‘URGENT: Voluntary Drug Recall Notice’.
AvKARE said customers can get a full refund, with those affected asked to fill out a form on the recall notice.
On the FDA’s website, it says the reason for recall is “cGMP deviations and lack of assurance of sterility”.
According to the FDS, cGMP regulations “contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product”.
“The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have,” the FDA says.
Tens of thousands of cases are affected by the recall, totalling more than 1.8 million cartons.
