A California company has recalled more than 3.1m bottles of lubricating eye drops because it had not properly tested, and thus could not prove, whether the products were sterile – not the first time a massive recall has occurred in the eye drop market, notes pharmacist C Michael White in The Conversation.
He writes:
These products are sold under several names at major retailers across the United States. The company, KC Pharmaceuticals, initiated the recall on 3 March 2026.
I am a clinical pharmacologist and pharmacist who has assessed risks of poor-quality manufacturing practices and lax oversight for prescription drugs, eye drops, dietary supplements and nutritional products in the United States for many years.
This recall is very large, potentially affecting more than 1m people. Using non-sterile eye drops that harbour bacteria and fungus can cause eye infections, which can become severe because the immune system has a hard time accessing the eyeball and fighting the microbes.
This is not the first time that a major recall has occurred in the eye drop market – and it is the second time since 2023 that the Food and Drug Administration has become aware of sterility issues at KC Pharmaceuticals.
Multiple products affected
Eight products are being recalled: 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 and Sterile Eye Drops Soothing Tears.
These products are sold under different company names, including Top Care, Best Choice, Good Sense, Rugby, Leader, Good Neighbor Pharmacy, Quality Choice, Valu Merchandisers, Geri Care, Walgreens, CVS and Kroger, and are sold at a number of stores.
As of early April, no infections from the recalled eye drops had yet been reported.
History of sterility issues
The FDA has many important public health roles: approving new drugs and medical devices; overseeing the manufacturing quality of prescription and over-the-counter drugs, dietary supplement and food products; and protecting the public from counterfeit medications.
With its limited personnel, the agency focuses its time on areas where the risks are greater. This means manufacturers of more dangerous products, or product types that were previously found to have issues, are inspected more frequently.
The FDA had inspected over-the-counter eye drop manufacturers only a few times before 2023, when cases of rare eye infections due to a drug-resistant Pseudomonas bacteria strain started occurring.
In total, 81 people from 18 states developed severe eye infections during the 2023 outbreak: 14 people suffered vision loss because of the product, an additional four people had their eyeballs removed, and four people died.
The agency identified two products as the culprits: Global Pharma’s EzriCare Artificial Tears and Delsem Pharma’s Artificial Tears and Eye Ointment.
Later in 2023, the FDA issued recalls for Dr Berne’s, LightEyez Limited, Pharmedica LLC and Kilitch Healthcare eye drop products for sterility issues. Kilitch Healthcare had serious quality lapses, in which the facility was filthy, employees were barefoot on the manufacturing floor, and the company fraudulently passed products that failed sterility tests.
Repeated manufacturing problem
At the time, the FDA also inspected KC Pharmaceuticals and issued the company a warning letter. The FDA was concerned that the manufacturer failed to establish and follow appropriate written procedures designed to prevent microbiological contamination.
Although the agency did not request a recall, it did ask that the company immediately change its protocols and consult outside experts to prevent these issues from recurring.
The current massive recall of KC Pharmaceuticals’ eye drop products suggests lingering quality control issues in the manufacturer’s California plant that need to be urgently addressed.
If the company had heeded the FDA’s recommendations, it would have detected the non-sterility issue before so many batches of the products were manufactured.
C. Michael White – Distinguished Professor of Pharmacy Practice, University of Connecticut, United States.
See more from MedicalBrief archives:
US recall on eye drops after severe drug-resistant infection
Deadly eye drops kill one, infect dozens more in UK