FDA Recalls Over 3 Million Bottles of Eye Drops Sold at Major Retailers

The recall is due to a lack of assurance of sterility in the products.

Apr. 3, 2026 at 3:22pm

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A ghostly, translucent X-ray image of the internal structure of an eye drop bottle, revealing the complex components in glowing lines against a dark background.An X-ray view of a recalled eye drop bottle exposes the internal components that failed to meet sterility standards.Pomona Today

The U.S. Food and Drug Administration has initiated a recall of over 3 million bottles of eye drops manufactured by K.C. Pharmaceuticals, Inc. and sold at major retailers like Walgreens, Kroger, and Publix. The recall is due to a lack of assurance of sterility in the products, which could pose a risk of temporary or medically reversible adverse health consequences.

Why it matters

Eye drops are a common over-the-counter product used by millions of Americans, so a large-scale recall like this raises concerns about product safety and quality control in the pharmaceutical industry. Sterility is a critical factor for eye drops, as any contamination could lead to serious eye infections.

The details

The recall covers a total of 8 different eye drop products sold under various brand names, including Dry Eye Relief Drops, Artificial Tears Sterile Lubricant Eye Drops, and Sterile Eye Drops Redness Lubricant. The products were manufactured by K.C. Pharmaceuticals, Inc., a company based in Pomona, California, and sold at major retailers like Walgreens, CVS, Rite Aid, Harris Teeter, Kroger, Publix, Good Neighbor Pharmacy, Good Sense, and Meijer.

  • The FDA initiated the recall on March 3, 2026.
  • In 2025, pharmaceutical manufacturer AvKare recalled more than 75,000 cases of eye drops following an FDA audit that found manufacturing deviations during production.

The players

K.C. Pharmaceuticals, Inc.

A pharmaceutical company based in Pomona, California that manufactured the recalled eye drop products.

Food and Drug Administration (FDA)

The U.S. government agency responsible for regulating and supervising the safety of food, drugs, and other products, including initiating the recall of the eye drops.

AvKare

A pharmaceutical manufacturer that recalled over 75,000 cases of eye drops in 2025 due to manufacturing deviations found by the FDA.

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The takeaway

This recall highlights the importance of strict quality control and sterility protocols in the manufacturing of over-the-counter pharmaceutical products. Consumers should be vigilant about checking for any recalls on products they use, and the FDA plays a crucial role in identifying and addressing potential safety issues to protect public health.