3M Bottles Of Eye Drops Recalled Over Sterility Concerns; Cause Unclear

More than 3 million bottles of over-the-counter eye drops sold nationwide have been recalled due to concerns about the sterility of the product, according to federal regulators.

The U.S. Food and Drug Administration said the voluntary recall affects 3,111,072 bottles of eye drops made by K.C. Pharmaceuticals of Pomona, California, including:

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

Reached by a Patch reporter, a spokesperson for K.C. Pharmaceuticals said the company has no comment on the recall.

According to the FDA, no injuries connected to the drops have been reported. The agency classified the recall in the Class II recall category, which is reserved for products where serious harm is unlikely or where health risks are typically temporary and reversible.

Regulators stated that it is unlikely that these products will cause significant harm but that sterility cannot be assured. The FDA did not say what prompted the recall.

Unlike prescription eye drops used to treat conditions such as glaucoma, dry eyes or retinal diseases, over-the-counter eye drops do not subject to an FDA review before they are sold, according to Gary Novack, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science.

“That said, they still need to be compliant with what is known as Current Good Manufacturing Practice. For eye drops, that means strict sterility, ensuring products are free from microorganisms like bacteria,” Novack said.

Drops that are not on the recall list should be safe to use, according to Dr. Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center who specializes in diseases that damage the surface layers of the eye.

“If you have any of the drops on the list, you should immediately throw them away,” Ma said.

For patients with dry eye, Ma recommends preservative-free drops that come in disposable single-use vials.

The eye drops were sold under various store and company labels, including Top Care, Best Choice, Good Sense, Rugby, Leader, Good Neighbor Pharmacy, Quality Choice, Valu Merchandisers, Geri Care, Walgreens, CVS and Kroger.

The eye drops, which have expiration dates ranging from April 30 to Oct. 31, 2026, were sold at CVS, Walgreens, Rite-Aid, Kroger, Harris Teeter, Dollar General, Circle K and Publix.

More details about the recalled eye drops are found on the FDA website.

Previous Eye Drop Recalls

K.C. Pharmaceuticals was not involved in the massive 2023 recall of eye drops the FDA said could cause temporary vision loss or blindness because of possible contamination with a drug-resistent Pseudomonas bacteria strain started occurring.

At least 81 people from 18 states developed severe eye infections, and 14 of them experienced vision loss, including four people who had their eyeballs removed, according to the Centers for Disease Control and Prevention. Four people died.

According to regulators, the products at the center of the 2023 outbreak were Global Pharma’s EzriCare Artificial Tears and Delsem Pharma’s Artificial Tears and Eye Ointment. Later in 2023, the FDA cited sterility issues in recalls for Dr. Berne’s, LightEyez Limited, Pharmedica LLC and Kilitch Healthcare eye drop products.

Although K.C. Pharmaceuticals was not part of the 2023 eye drop recalls, the FDA sent a warning letter demanding immediate protocol changes and consultation with outside experts to prevent contamination.

The agency said its inspection revealed the firm failed to establish and follow adequate written procedures to prevent microbiological contamination in sterile drug products, including proper validation of aseptic and sterilization processes.

The FDA also cited a failure to perform operations in appropriately defined or controlled areas, increasing the risk of contamination or mix-ups during aseptic processing, and lacked sufficient written procedures for the cleaning and maintenance of equipment.