Eye drops recall affects 3 million bottles over safety

A major eye drops recall is affecting more than 3 million bottles across the United States after the Food and Drug Administration raised concerns about product sterility.

The recall was issued voluntarily by K.C. Pharmaceuticals, which manufactures several over-the-counter eye care products sold under multiple brand names.

Products sold at major retailers nationwide

Among the recalled items are various formulations marketed as “Artificial Tears,” “Dry Eye Relief,” and “Sterile Eye Drops,” all in 0.5 fl oz (15 mL) bottles.

The recall began in early March and includes more than 3.1 million units.

FDA flags sterility concerns

According to the FDA, the recall stems from a “lack of assurance of sterility,” a critical issue for products applied directly to the eyes.

The agency classified the situation as a Class II recall, meaning the products could potentially cause temporary or medically reversible health effects.

So far, no injuries or adverse events have been reported in connection with the recalled eye drops.

What consumers should know

Under a Class II recall, patients may continue using the product unless otherwise directed. However, health authorities typically advise caution and recommend checking product labels against recall notices.

Consumers who purchased any of the affected eye drops should monitor updates from the FDA and consult a healthcare provider if they experience irritation or unusual symptoms.

The eye drops recall highlights ongoing concerns around manufacturing quality and safety standards in over-the-counter health products.