Nearly two million cartons of eyedrops have been recalled due to concerns about quality.
BRS Analytical Service, LLC announced the urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release.
The recall comes after a Food and Drug Administration (FDA) audit 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.
Although it’s unclear what health risks may be posed, CGMP deviations could lead to “unacceptable quality” of the recalled eyecare solutions, and it’s “not possible to rule out patient risks resulting from use of these products,” according to AvKARE.
The five solutions that have been recalled are Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution.
Eye solutions were shipped from May 26, 2023, until April 21, 2025. Consumers 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.
Consumers should throw away these products immediately or return them to the place of purchase to get a full refund. You can find a list of all the eyecare products that were a part of this recall here.
According to the FDA, the recall was also issued due to a “lack of assurance of sterility” in these products. The recall 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,” according to the FDA.
The eyecare solutions are one of many everyday products that have been recalled in 2025. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon.
The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
In March, the FDA announced a recall of 1,068 bottles of Henkel’s Tec Italy Totale Shampoo because they may contain the bacteria Klebsiella oxytoca, which can cause infections in the eyes, nose, and skin.
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