K.C. Pharmaceuticals Recalls Over 3.1 Million Eye Drop Bottles Due to Sterility Concerns

K.C. Pharmaceuticals has initiated a recall of more than 3.1 million bottles of eye drops due to concerns regarding their sterility. The recall, announced on March 3, impacts products sold under various brand names at major retailers across the U.S. The U.S. Food and Drug Administration (FDA) has classified this action as a "Class II" recall.

Recall Details

The recall involves over 3.1 million bottles of eye drops manufactured by K.C. Pharmaceuticals. The company initiated the recall on March 3 following a notice from the FDA regarding sterility concerns with the products.

The FDA's "Class II" recall classification indicates that exposure to the product may lead to temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

Affected Products and Retailers

Eight distinct brands manufactured by K.C. Pharmaceuticals are involved in the current recall. These products were sold under various brand names, including Dry Eye Relief Eye Drops and Artificial Tears Sterile Lubricant Eye Drops.

The affected eye drops were distributed to major retailers, including Walgreens, CVS, Rite Aid, H-E-B, and Harris Teeter. The largest single lot included in the recall comprises over 1 million bottles sold under the Dry Eye Relief Eye Drops brand.

Background

This recall follows a separate major eye drops recall that occurred in 2023. That previous recall involved a different manufacturer and was initiated due to suspected bacterial contamination in their products.