FDA Announces Voluntary Recall of 3.1 Million Eye Drop Bottles Over Sterility Concerns

The U.S. Food and Drug Administration (FDA) has issued a voluntary recall of more than 3.1 million bottles of over-the-counter eye drops sold at major retailers, including Walgreens, CVS, and Kroger. The recall was initiated on March 3 and classified by the FDA on March 31 due to concerns about sterility.

While no illnesses or injuries have been reported in connection with the recalled products, experts emphasize that such recalls can undermine public trust in medical products. A 2023 outbreak linked to eye drops resulted in over 80 infections and four deaths in the United States.

California-Based Company Behind the Recall

The recall is being conducted by K.C. Pharmaceuticals, a California-based pharmaceutical company. The products were distributed through major national retailers, including Walgreens, Kroger, and CVS.

Which Eye Drop Brands Are Affected?

The recalled eye drop brands include:

• Sterile Eye Drops
• AC Eye Drops
• Advanced Relief Dry Eye Relief Eye Drops
• Ultra Lubricating Eye Drops
• Sterile Eye Drops Original Formula
• Sterile Eye Drops Redness Lubricant
• Sterile Eye Drops Soothing Tears
• Artificial Tears Sterile Lubricant Eye Drops

Consumers are urged to discontinue use immediately and discard these products.

FDA Classifies Recall as Class II

The FDA has classified the recall as a Class II recall, which means that "using the drug may cause temporary health consequences, but the probability of a serious health issue is remote." The rationale for the recall is listed as a "lack of assurance of sterility."

This designation does not confirm contamination but indicates a potential lapse in the manufacturing process that could compromise sterility.

Retailers Respond to the Recall

Retailers are working to address the recall and assist customers. Healthline reached out to several retailers for comment:

• Walgreens and Kroger did not respond by the time of publication.
• A CVS representative stated:

  "We’re committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers’ needs. While the four recalled items sold by CVS were discontinued nearly a year ago, we’re fully cooperating with the voluntary recall."

The CVS representative added that customers who purchased these products may return them for a refund.

Experts Raise Concerns About Eye Drop Safety

Although no illnesses have been reported due to this recall, experts warn that widespread recalls can have broader implications. Gary Novack, PhD, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science, noted:

"We don’t know if they really were contaminated. If they were, we don’t know what type of microbe. We don’t know any of that. All we know is that the manufacturer said there’s an issue with sterility in these products."

Doctors and public health experts emphasize the importance of maintaining trust in medical products, even when recalls are precautionary.