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More than three million bottles of over-the-counter eye drops were voluntarily recalled from the U.S. market by KC Pharmaceuticals Inc., a company based in Pomona, California, following a warning from the Food and Drug Administration (FDA) regarding a lack of sterility assurance in their manufacturing process.
The recall involves exactly 3,111,072 containers distributed across major retail chains such as CVS, Walgreens, Rite Aid, Kroger, H-E-B, Publix, Harris Teeter, Meijer, Dollar General, and Circle K, among others.
The company initiated the process on March 3, and on the 31st of that same month, the FDA formally granted Class II status to the recall, indicating that the products could cause health effects that are "temporary or medically reversible," with a remote probability of serious complications.
The lack of guaranteed sterility does not necessarily mean that the products are contaminated, but rather that the manufacturing process cannot certify that potential microbial contamination has been prevented.
The recall includes eight different types of products, all in 15 ml bottles, sold under various brand names, including "Dry Eye Relief Eye Drops," "Sterile Eye Drops," "Artificial Tears Sterile Lubricant Eye Drops," "GeriCare Artificial Tears Lubricant Eye Drops," "CVS Lubricant Eye Drops Redness Reliever," and "CVS Lubricant Eye Drops Dry Eye."
The largest recall involves over a million bottles of Dry Eye Relief Eye Drops, sold at Rite Aid, H-E-B, and Harris Teeter.
Consumers can identify the affected products by the batch codes printed on the labels, which start with the letters AC, AR, LT, SU, RG, RL, SY, or AT, with expiration dates between April and October 2026.
To date, no injuries or health issues have been reported associated with the use of the recalled products.
According to the FDA, during a Class II recall, consumers may continue to use the medication unless the company or the agency indicates otherwise.
CVS confirmed that it has removed the products from all its physical stores and CVS.com, and activated a "Do Not Sell" notice at the checkout to prevent their sale. A spokesperson for the chain stated, "We are committed to ensuring that the products we offer are safe, function as intended, comply with regulations, and meet customer needs." Additionally, it was reported that customers who purchased these eye drops can return them at any CVS store for a full refund.
KC Pharmaceuticals has not responded to requests for comment from major media outlets, and it is unclear what prompted the recall.
This case fits into a broader pattern of FDA alerts regarding ophthalmic drops with sterility issues. The most serious incident occurred in 2023 with EzriCare Artificial Tears, which were contaminated with antibiotic-resistant bacteria, leading to over 80 infections in at least 18 states, 14 cases of permanent vision loss, and four deaths.
Unlike that recall, classified as Class I due to its high risk, the current one from KC Pharmaceuticals is Class II, with a risk considered low for serious consequences.
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