Photo: Predrag Popovski / Moment / Getty Images
An urgent nationwide recall has been issued for over 1.8 million cartons of eye drops due to potential sterility issues that could lead to serious eye infections, vision loss, or even blindness. The recall, announced by the distributor AvKARE and the Food and Drug Administration (FDA), affects several products intended to relieve dry eye symptoms, including Artificial Tears Ophthalmic Solution and Carboxymethylcellulose Sodium Ophthalmic Gel 1%. These products were distributed between May 26, 2023, and April 21, 2025.
You can find a full list of the products and their lot numbers here.
The recall notice highlights a "lack of assurance of sterility" in the manufacturing process, which was identified during an FDA audit. Although the specific manufacturing issue was not disclosed, the FDA warns that non-sterile eye drops can lead to severe infections. In a similar case in 2023, 50 infections across 11 states were linked to contaminated eye drops, resulting in one death and several cases of permanent blindness.
AvKARE, based in Pulaski, Tennessee, urges consumers to stop using the recalled products immediately and advises retailers to remove them from shelves and return them for a full refund. The recall is especially concerning during allergy season when more people rely on eye drops for relief.