The company voluntarily began the recall on Tuesday, March 3, 2026, according to a notice issued by the U.S. Food and Drug Administration (FDA). The agency cited a “lack of assurance of sterility” as the primary reason for the action, a concern that could potentially expose users to contamination risks. Sterility is a critical requirement for ophthalmic products, as compromised solutions may lead to irritation or infection.
Within a week of the initial announcement, the FDA classified the recall as a Class II event. This designation indicates that use of the affected products may cause temporary or medically reversible adverse health effects, though the likelihood of serious health consequences is considered low. As of now, there have been no confirmed reports of adverse reactions linked to the recalled products.
The recall includes multiple types of commonly used eye drops, such as Dry Eye Relief Drops, Artificial Tears Sterile Lubricant Eye Drops, and Ultra Lubricating Eye Drops, among others. These products are widely used to treat dryness, redness, and irritation, making the recall significant for consumers who rely on over-the-counter eye care solutions.
In total, more than 3 million units are affected, spanning a broad range of formulations and product lines. The scale of the recall highlights ongoing concerns within the pharmaceutical industry regarding manufacturing quality and contamination risks, particularly in sterile products
This development follows a series of similar recalls in recent years involving eye drops and artificial tears, many of which were also linked to potential contamination or sterility issues. Consumers are advised to check their products carefully and discontinue use of any items included in the recall while seeking guidance from healthcare providers if needed.
