Eye Drop Recall Highlights Ongoing Sterility Concerns in OTC Manufacturing

A California-based manufacturer has recalled more than 3.1 million bottles of lubricating eye drops after failing to properly test for sterility. The recall, initiated on March 3, 2026, by K.C. Pharmaceuticals, affects multiple products sold nationwide under various retail and private-label brands.

The scale of the recall is significant and may impact more than one million consumers. While no infections have been reported as of early April, the situation underscores continued concerns surrounding manufacturing quality and regulatory oversight in the over-the-counter eye care market.

Scope of the Recall

Eight eye drop products are included in the recall:

• 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
• Sterile Eye Drops Soothing Tears

These products were distributed under multiple brand names, including Top Care, Best Choice, Good Sense, Rugby, Leader, Good Neighbor Pharmacy, Quality Choice, Valu Merchandisers, Geri Care, Walgreens, CVS, and Kroger.

Retail distribution included major national chains such as Walgreens, CVS, Rite Aid, Kroger, Harris Teeter, Dollar General, Circle K, and Publix. The affected products carry expiration dates ranging from April 30, 2026, to Oct. 31, 2026, and were sold beginning in April 2025.

Health Risks and Consumer Guidance

The primary concern involves the potential use of nonsterile eye drops. Products contaminated with bacteria or fungi can cause eye infections, which may become severe due to the immune system’s limited ability to respond within the eye.

Although no infections have been reported in connection with this recall, consumers are advised to stop using affected products and return them for a refund. Symptoms that may indicate infection include redness, discharge, swelling, irritation, vision changes, or pain. Individuals experiencing these symptoms are advised to seek medical attention and report the issue to the Food and Drug Administration.

Consumers can verify whether their product is part of the recall by reviewing product names, lot numbers, and expiration dates listed on the FDA website.

Regulatory Oversight and Historical Context

The FDA oversees drug and medical product safety, including manufacturing quality for both prescription and over-the-counter products. Due to resource constraints, the agency prioritizes inspections based on risk levels and prior compliance issues.

Before 2023, inspections of over-the-counter eye drop manufacturers were relatively infrequent. However, a multistate outbreak in 2023 prompted increased scrutiny. That outbreak involved 81 reported infections across 18 states linked to contaminated eye drops. The consequences included 14 cases of vision loss, four eye removals, and four deaths.

The FDA identified Global Pharma’s EzriCare Artificial Tears and Delsem Pharma’s Artificial Tears and Eye Ointment as the sources. Later that year, additional recalls were issued for products from Dr. Berne’s, LightEyez Limited, Pharmedica LLC, and Kilitch Healthcare. In one case, inspectors documented significant manufacturing deficiencies, including unsanitary conditions and falsified sterility testing results.

Prior FDA Action Involving K.C. Pharmaceuticals

K.C. Pharmaceuticals was previously inspected by the FDA in 2023. At that time, the agency issued a warning letter citing concerns about the company’s failure to implement adequate procedures to prevent microbiological contamination.

Although no recall was required at that time, the FDA instructed the company to revise its protocols and consult external experts. The current recall indicates that sterility assurance issues persisted.

The affected products were manufactured at the company’s Pomona, California, facility. The inability to confirm sterility across multiple batches led to the large-scale recall.

Ongoing Monitoring

As of early April 2026, the FDA has not received reports of infections associated with these products. The agency continues to provide updated information on affected lot numbers and expiration dates through its public database.

This recall follows a series of similar events in recent years and reflects continued regulatory focus on manufacturing practices within the eye care product segment.