A California-based pharmaceutical company is recalling more than 3.1 million bottles of eye drops distributed across the United States due to concerns about product sterility, according to the U.S. Food and Drug Administration.
The recall involves products manufactured by K.C. Pharmaceuticals, Inc., which voluntarily pulled multiple eye drop brands after identifying what the FDA described as a “lack of assurance of sterility.”
Affected products were distributed nationwide through major retailers and outlets, including Kroger, Walgreens, H-E-B, and military exchanges.
The FDA has classified the action as a Class II recall, meaning use of the products could cause temporary or medically reversible health effects, though the risk of serious harm is considered low.
Products included in this recall
The recall spans several formulations and bottle sizes, totaling more than 3.1 million units:
- 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 March 3 and officially classified by the FDA on March 31. Consumers can review specific lot numbers and UPC codes through the FDA’s enforcement report.
This latest recall adds to a growing list of safety concerns involving over-the-counter eye care products in recent years. Previous recalls have cited issues such as contamination with foreign particles, unsafe manufacturing conditions, and even fungal contamination that posed a risk of vision damage.
Health officials advise consumers to stop using any recalled products immediately and consult a healthcare provider if they experience symptoms such as eye irritation, redness, pain, or changes in vision.