FDA flags 3.1 million store-brand eye drops recalled over sterility concerns

More than 3.1 million bottles of store-brand eye drops sold at CVS, Walgreens $WBA 0.00%, Kroger, and other major retailers have been voluntarily recalled after the Food and Drug Administration cited a “lack of assurance of sterility” from the manufacturer, KC Pharmaceuticals of Pomona, California.

The recall affects 3,111,072 bottles from eight product lines, all made by KC Pharmaceuticals and sold under different store brands. Products include Dry Eye Relief Eye Drops, Sterile Eye Drops, Advanced Relief Eye Drops, and Artificial Tears Sterile Lubricant Eye Drops. The recalled bottles have expiration dates between April 30 and July 31, 2026.

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The voluntary recall began on March 3. By March 31, the FDA had labeled it as a Class II recall. This category is for products where health risks are usually temporary and reversible, or where serious harm is unlikely. Regulators said that serious harm from these products is unlikely.

No contamination has been found, and there have been no reports of injuries or infections linked to these products. The FDA notice did not say what caused the recall, and KC Pharmaceuticals has not yet responded to requests for comment from news outlets.

Under typical Class II recall guidance, the FDA does not require people to immediately stop using the affected product, provided the manufacturer has not issued separate instructions to do so. Refunds are available for anyone who bought the recalled products and wishes to bring them back to the retailer. A CVS spokesperson, speaking to ABC News, noted that the chain’s four implicated products had already been pulled from its shelves roughly a year earlier, and confirmed the retailer’s support for the recall process.

The recalled products were sold under multiple store brand names, including CVS, Walgreens, Kroger, H-E-B, Rite Aid, Discount Drug Mart, Gericare, and Best Choice. A full list of affected products, including lot numbers and UPC codes, is available on the FDA’s website.

Non-sterile eye drops carry the risk of bacterial or fungal contamination. Dr. Nicole Bajic, an ophthalmologist at the Cleveland Clinic, warned that sterility in eye drops is non-negotiable. “Whenever we talk about using eye drops for the ocular system, it’s really important that there’s no bacterial contamination because that can cause significant and sight-threatening infections,” she told Yahoo News. Bajic advised anyone whose symptoms — including pain, visual disturbances, or sensitivity to light — are not resolving on their own to consult a doctor promptly.

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