“Are My Eye Drops Safe?” is a search tool created by the Dry Eye Foundation to help consumers and health care professionals quickly identify whether an OTC eye drop sold in the US has any known safety concerns.
This is a database of over-the-counter eye drops that are sold in the US. It includes many products that are not authorized for sale in the US but are imported illegally through sales on e-commerce platforms. We cannot guarantee that all brands and products legitimately distributed in the US are included. Users are encouraged to notify Dry Eye Foundation about any eye drops missing from the database, including generic (“house brand”) products.
Yellow or red alerts are assigned to products when applicable. These range from recalls, to FDA warnings, to violations of basic “honor system” rules for manufacturers. Click here for a detailed explanation of the Dry Eye Foundation’s safety alerts system.
Dry Eye Foundation conducts e-commerce surveillance to identify OTC eye drops being sold in the US and monitors relevant FDA announcement pages for new announcements.
This tool is needed in order to reduce confusion and improve accessibility of information about recent warnings and known risks.
In February 2023, the FDA warned that Ezricare Artificial Tears, a cheap generic, had been linked to treatment-resistant infections. It has since been officially blamed for 4 deaths and 18 cases of blindness or surgical removal of an eyeball. Between February and September 2023, the FDA has stepped up its enforcement activities related to over-the-counter eye drops, issuing 15 different public warnings, recall notices, safety communications and manufacturer warnings involving 50 different over-the-conter eye drops manufactured or distributed by 18 different companies.
The idea that an inexpensive eye drop could cause serious harm, let alone blind or kill someone, is new to most people, and has even resulted in a change to the FDA’s messaging. For example, in recent warning letters to manufacturers, the FDA says:
Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.
But there is confusion about which eye drops to worry about. Ever since the EzriCare Artificial Tears tragedy, the press has frequently reported about eye drops. It’s not always clear what the news reports mean, whether the same or different eye drops are involved, or how serious the public health risks are.
Dry Eye Foundation has conducted extensive research into eye drops sold in e-commerce in the US, with disturbing results. Hundreds of eye drops are being sold online that are not authorized for sale in the US and not compliant with basic FDA standards. This is a rapidly escalating trend.
E-commerce has fundamentally altered the landscape for eye drop sales. This is because of the intersection of two huge lapses: e-commerce platforms which fail to scrutinize any OTC eye drop listings, resulting in the popularization of eye drops that are not even registered for sale in the US, and an outdated regulatory framework that relies heavily on the industry to police itself for compliance.
As a nonprofit serving the ocular surface disease community, we want to ensure our community has access to timely, comprehensible information that helps them assess risks. This database is our way of filling the information gap with easy-to-understand safety flags.