Eyedrops have been recalled amid fears the products are not safe or sterile.
The urgent recall of a total of five eye care products has been made this morning by an American manufacturer, which has urged any users of the medication to stop with immediate effect.
BRS Analytical Service, LLC, announced the urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release.
The affected products are:
- Artificial Tears Ophthalmic Solution;
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution
- Lubricant Eye Drops Solution
- and Polyvinyl Alcohol Ophthalmic Solution
The US Food and Drug Administration (FDA) say they found problems with the product in a recent audit, saying they “identified violations of Current Good Manufacturing Practice (CGMP).”
CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
The company has not revealed what the health risks could be from the products, but they have advised customers to stop using any of the listed products immediately, saying they are of “unacceptable quality”, adding: “It’s not possible to rule out patient risks resulting from use of these products.”
The affected batch of eye solutions were shipped from May 26, 2023, until April 21, 2025.
Customers are being asked to fill out the “Quantity to Return” section and the customer information block on the recall notice, which can be faxed or emailed to AvKARE. People are urged to submit the forms even if they don’t have the recalled eyecare solutions anymore.
They have also been advised to chuck away these products immediately or return them to the place of purchase to get a full refund.
The FDA say the the recall was also made due to a “lack of assurance of sterility” in these products, and affects “more than 1.8 million cartons of eye drops.”
On May 6, the recall was identified as a Class II one, which is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”.
