Recent product warnings have focused sharply on the safety of over-the-counter ophthalmic products, particularly artificial tears. Any product applied to the eyes must meet rigorous standards of sterility to prevent infection. Failure to meet this standard can lead to severe consequences, prompting immediate regulatory action. Understanding which eye drops were recalled and the reasons behind these actions is important for consumers who rely on these products.
Identifying the Major Recalls and Affected Brands
The most serious and widely publicized recall centered on artificial tears distributed under the brand names EzriCare and Delsam Pharma. These products, including EzriCare Artificial Tears and Delsam Pharma Artificial Tears and Ointment, were manufactured by Global Pharma Healthcare Private Limited and distributed nationwide. The recall began in February 2023 after investigations by the FDA and CDC linked the drops to a multi-state outbreak of severe infections.
A separate, broader recall later in 2023 involved numerous store-brand eye drops manufactured by Kilitch Healthcare India Limited. This second recall affected products sold under major retail labels, including CVS Health, Leader, Rite Aid, Target Up&Up, and Walmart’s Equate Hydration PF. These actions demonstrated widespread sterility concerns across several products sourced from foreign manufacturers.
The Primary Cause for Recall
The EzriCare and Delsam Pharma recalls were tied to the presence of a drug-resistant bacterium in the product bottles. The specific contaminant identified was an extremely rare strain of Pseudomonas aeruginosa known as VIM-GES-CRPA. This organism is concerning because it is resistant to carbapenems, a class of antibiotics often used as a last resort for treating severe bacterial infections.
The contamination was traced back to a failure in manufacturing practice, specifically a lack of sterility assurance at the production facility. Ophthalmic drugs must be manufactured under strictly sterile conditions because they bypass the body’s natural defenses when applied to the eye. The VIM-GES-CRPA strain had never been documented in the United States prior to this outbreak.
Health Risks and Symptoms of Contamination
The consequences of using the contaminated EzriCare and Delsam eye drops were serious, resulting in permanent vision loss in multiple patients. In the most severe cases, the infection spread from the eye to the bloodstream, contributing to hospitalizations and at least four reported deaths nationwide. For some individuals, the infection required enucleation, the surgical removal of the eyeball, to prevent the disease from spreading.
Consumers who developed an infection typically reported a specific set of symptoms requiring immediate medical attention. These include increased eye pain or discomfort, unusual discharge, redness of the eye or eyelid, and heightened sensitivity to light. Blurred vision or the sensation of a foreign body in the eye are also common indicators of an ocular infection.
Immediate Steps for Consumers
Anyone who possesses the recalled eye drops should immediately stop using them, even if they have not experienced symptoms. Dispose of the drops safely by discarding them in the trash, rather than pouring them down a drain or flushing them, to prevent environmental contamination. Consumers should verify if their product is on the recall list by checking the FDA’s official announcements for specific brand names and product codes.
If a person has used the recalled products and is experiencing any symptoms of an eye infection, they must contact a healthcare provider or eye doctor right away. Early diagnosis and treatment are essential for managing infections caused by drug-resistant organisms like VIM-GES-CRPA. Consumers and healthcare professionals are encouraged to report any adverse events or product quality issues through the FDA’s MedWatch Adverse Event Reporting program.