Recall impacts over 3.1 million eye drop products distributed nationwide: FDA

TOPEKA (KSNT) – A California pharmaceutical company is recalling over 3 million bottles of eye drops distributed nationwide.

The Food and Drug Administration (FDA) reports that K.C. Pharmaceuticals, Inc., based out of Pomona, Calif., is voluntarily recalling various eye drop products distributed across the country. The stated reason for the recall is a “lack of assurance of sterility” in the products.

The FDA said the eye drops were distributed by companies such as Kroger, Walgreens, H-E-B, Military Exchanges and others. The agency assigned the recall the ranking of a “Class II” recall, which means exposure to the product could cause temporary or reversible health problems.

The company is recalling more than 3.1 million eye drop products across several different labels and sizes. The products recalled include:

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

The recall was initiated on March 3 and then classified on March 31. You can find more information on the recalled products, including lot codes and UPC codes, in the FDA’s enforcement report.

The recall is the latest in a string of warnings about eye products in recent years. One recall of eye drops filed earlier this year was due to the “presence of glass-like particles” in the products. Another batch of eye drops recalled last year was blamed on unsafe manufacturing practices. In late 2024, the FDA announced yet another eye drop recall because the drops were possibly contaminated with fungus that could cause vision damage.