K.C. Pharmaceuticals Recalls Over 3.1 Million Bottles of Eye Drops Due to Sterility Testing Issues

C. 1 million bottles of lubricating eye drops on March 3, 2026. The recall stems from the company's failure to conduct adequate testing to verify the sterility of the products. These eye drops are available under multiple brand names at retailers across the United States.

The affected products include eight types: Dry Eye Relief Eye Drops, Artificial Tears Sterile Lubricant Eye Drops, Sterile Eye Drops Original Formula, Sterile Eye Drops Redness Lubricant, Eye Drops Advanced Relief, Ultra Lubricating Eye Drops, Sterile Eye Drops AC, and Sterile Eye Drops Soothing Tears.

They are marketed by brands such as Top Care, Best Choice, Good Sense, Rugby, Leader, Good Neighbor Pharmacy, Quality Choice, Valu Merchandisers, Geri Care, Walgreens, CVS, and Kroger. Expiration dates for the recalled bottles range from April 30, 2026, to October 31, 2026.

These products were sold at stores including Walgreens, CVS, Rite Aid, Kroger, Harris Teeter, Dollar General, Circle K, and Publix. Consumers who purchased eye drops since April 2025 should check if their product matches the recalled names. Detailed information on lot numbers and expiration dates is available on the FDA website.

Determining Recall Involvement To identify if a product is part of the recall, consumers can refer to the FDA's table listing product names, lot numbers, and expiration dates.

For instance, Sterile Eye Drops AC with lot number AC24E01 and an expiration date of May 31, 2026, is included. Products with matching names but different lot numbers or expiration dates are not affected and can continue to be used. If a recalled product is identified, users should discontinue use immediately and return it to the retailer for a refund.

As of early April 2026, the FDA has received no reports of infections associated with these eye drops. However, potential symptoms of eye infections include redness, stuck eyelids, unusual discharge, vision changes, swelling, pain, itchiness, or irritation. Individuals experiencing such symptoms after using the products should seek medical attention and, if possible, report to the FDA.

Nonsterile eye drops can introduce bacteria and fungi, leading to infections that are difficult for the immune system to combat due to limited access to the eyeball.

Background on Eye Drop Safety Issues This recall marks the second instance since 2023 in which the FDA has identified sterility concerns at K.

C. Pharmaceuticals. In 2023, the FDA inspected the company's facility in Pomona, California, and issued a warning letter regarding inadequate procedures to prevent microbiological contamination. The agency required the company to update its protocols and consult external experts, though it did not mandate a recall at that time.

The broader context involves prior outbreaks linked to contaminated eye drops. In 2023, an outbreak of infections from a drug-resistant Pseudomonas bacteria strain affected 81 people across 18 states, resulting in 14 cases of vision loss, four enucleations, and four deaths. The FDA traced the issue to products from Global Pharma and Delsem Pharma.

Later in 2023, the FDA oversaw recalls of eye drops from Dr. Berne’s, LightEyez Limited, Pharmedica LLC, and Kilitch Healthcare due to sterility problems. Inspections at Kilitch Healthcare revealed significant quality issues, including unsanitary conditions and falsified sterility test results.

The FDA's oversight of over-the-counter eye drop manufacturers increased following these events, as the agency prioritizes inspections based on risk levels and past compliance history. The FDA's responsibilities include approving drugs and devices, monitoring manufacturing quality for prescription and over-the-counter products, and addressing counterfeit medications.

With limited resources, the agency focuses on higher-risk areas.

This recall highlights ongoing challenges in ensuring sterility in eye drop production, potentially affecting over a million consumers who may have purchased the products.