California-based KC Pharmaceuticals announced a recall of more than 3 million over-the-counter eye drops after concerns arose about potential contamination and lack of sterility assurance.
The U.S. Food and Drug Administration (FDA) confirmed that the recall is classified as a Level 2 recall, meaning there is a temporary and reversible risk to the eyes if the products are used, although no bottles have yet been found to be contaminated.
The drops were sold nationwide in 0.5-ounce bottles and were available at CVS, Walgreens, Kroger and H-EB stores, with a shelf life of May or October of this year.
The recalled products included several types, most notably:
One million bottles of Dry Eye Relief Eye Drops.
590,000 bottles of Artificial Tears Sterile Lubricant Eye Drops.
378,000 bottles of Sterile Eye Drops Original Formula.
315,000 bottles of Sterile Eye Drops Redness Lubricant.
303,000 bottles of Eye Drops Advanced Relief.
245,000 bottles of Ultra Lubricating Eye Drops.
182,000 bottles of Sterile Eye Drops AC.
74,000 bottles of Sterile Eye Drops Soothing Tears.
The Food and Drug Administration indicated that the codes for the recalled batches could be viewed on its official website.
The problem is likely related to inadequate hygiene standards at the manufacturing facility, as the lack of guaranteed sterilization suggests the possibility of the drops being contaminated with bacteria or particles that could harm the eye.
It is worth noting that a similar recall occurred in 2023 after the discovery that eye drops produced in India were contaminated with a deadly bacterium (Pseudomonas aeruginosa), which led to the illness of 81 patients, permanent vision loss in 18 people, and the death of four others.
Signs of potential complications from using eye drops include persistent redness, pain, abnormal yellow discharge, increased sensitivity to light, and blurred vision. Doctors advise anyone experiencing adverse effects to contact their ophthalmologist immediately, especially in cases of sudden pain or a sharp change in vision.
