Sterile Eye Drops Recall Affects More Than 3M Bottles Sold at Kroger, Walgreens and Elsewhere

Recalled eye drops may have been compromised during manufacturing, raising concerns about potential sterility issues and an increased risk of infection.

The U.S. Food and Drug Administration (FDA) announced a K.C. Pharmaceuticals eye drop recall on March 31, affecting more than 3.1 million bottles of over the counter products that may be contaminated, increasing the risk of infection and vision problems.

Sterile eye drops are intended to be manufactured under strict conditions that prevent exposure to bacteria and other harmful microorganisms, making them safe for direct use in the eyes. Because the eye is highly sensitive and vulnerable to infection, any breakdown in sterility controls during production can introduce pathogens that may cause irritation, infection or in severe cases, vision damage.

In recent years, regulators have repeatedly identified manufacturing deficiencies that raised concerns about whether proper sterility safeguards were maintained. Last year, more than 1.8 million AvKARE eye drop cartons were recalled after potential lapses in quality control created a risk of bacterial contamination. In 2023, at least 26 over the counter eye drop products sold by major retailers were also recalled following findings of unsanitary manufacturing conditions.

Those earlier recalls triggered a wave of Artificial Tears eye drop lawsuits, with plaintiffs alleging manufacturers failed to ensure products were produced in sterile environments. Just last year, consumers filed a class action lawsuit alleging they were misled into purchasing Systane eye drops marketed as safe and effective before a large-scale recall linked to suspected fungal contamination tied to manufacturing issues.

Sterile Eye Drops Recall

K.C. Pharmaceuticals initiated the recall on March 3, which the FDA later classified as a Class II recall on March 31, indicating that use of the affected products could cause temporary or medically reversible health problems, with a low risk of serious injury.

According to the FDA enforcement report, the recall was issued due to a “lack of assurance of sterility,” meaning the manufacturer could not confirm that the products were produced under conditions necessary to prevent microbial contamination. This type of deficiency often points to potential problems in the aseptic manufacturing or filling process, where even minor lapses can allow bacteria or other contaminants to enter products intended for direct use in the eye.

The recall impacts a wide range of private label and store brand products distributed nationwide and sold under a variety of names at major retail chains, including Walgreens, Kroger, CVS, Harris Teeter, H-E-B, military exchanges, and through other wholesale and pharmacy distribution channels.

In total, more than 3.1 million bottles are affected across multiple formulations and brand names. The following products were included in the recall:

• 182,000 bottles of Sterile Eye Drops AC
• 303,000 bottles of Eye Drops Advanced Relief
• 1,024,000 bottles of Dry Eye Relief Eye Drops
• 245,000 bottles of Ultra Lubricating Eye Drops
• 378,000 bottles of Sterile Eye Drops Original Formula
• 315,000 bottles of Sterile Eye Drops Redness Lubricant
• 74,000 bottles of Sterile Eye Drops Soothing Tears
• 590,000 bottles of Artificial Tears Sterile Lubricant Eye Drops

Specific lot numbers, expiration dates and UPC codes are listed in the FDA recall notice. Consumers are advised to check packaging carefully if they have recently purchased store brand eye drops.

While no widespread injuries have been publicly linked to this recall, the FDA warning underscores the risks associated with products that lack verified sterility. In similar cases, contamination has been tied to infections that required medical treatment and, in rare instances, resulted in vision complications.

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