Overview

• The recall affects five ophthalmic products distributed nationwide between May 2023 and April 2025, including artificial tears and lubricant eye drops.
• The FDA audit revealed deviations from Current Good Manufacturing Practice (cGMP) and a lack of sterility assurance, prompting the recall's Class II classification.
• More than 1.8 million cartons of eye care products are being withdrawn, with potential risks of temporary or reversible health effects identified.
• Consumers are advised to stop using the products immediately and return them for a full refund, including shipping costs, as per AvKARE's instructions.
• This recall follows a series of recent eye care product safety issues, highlighting the FDA's increased scrutiny of manufacturing practices.