Overview

• The recall affects five over-the-counter ophthalmic solutions, including artificial tears and lubricant eye drops, distributed between May 2023 and April 2025.
• FDA audits revealed manufacturing deviations and a lack of sterility assurance, leading to the voluntary recall classified as Class II for potential reversible health risks.
• More than 1.8 million cartons of eye care products are impacted, with consumers urged to stop use immediately and return items for a full refund, including shipping costs.
• BRS Analytical Service and distributor AvKARE have acknowledged the products could pose safety risks due to 'unacceptable quality,' though no specific health hazards have been confirmed.
• The recall highlights ongoing regulatory challenges in ensuring compliance with Current Good Manufacturing Practices in the eye care product supply chain.