FDA Issues Warning Against 26 Eye Drop Products Over Infection Risk

Date: October 30, 2023

Federal regulators have issued a warning against the use of 26 over-the-counter eye drop products due to potential infection risks. The Food and Drug Administration (FDA) recently discovered harmful bacteria and "insanitary conditions" at a manufacturing facility responsible for producing these eye drops, raising concerns about their safety.

Products Affected:

The FDA's warning applies to a range of eye drop products sold under various store brands and labels, including CVS Health, Rite Aid, Target Up & Up, Leader, Rugby, and Velocity Pharma. Some of the affected products include:

• CVS Health:

  • Lubricant Eye Drops

  • Lubricant Gel Drops

  • Multi-Action Relief Drops

• Rugby (Cardinal Health):

  • Lubricating Tears Eye Drops

  • Polyvinyl Alcohol 1.4% Lubricating Eye Drops

• Leader (Cardinal Health):

  • Dry Eye Relief

  • Eye Irritation Relief

• Rite Aid:

  • Lubricant Eye Drops

  • Gentle Lubricant Gel Eye Drops

  • Multi-Action Relief Drops

• Target:

  • Up&Up Dry Eye Relief Lubricant Eye Drops

  • Up&Up Extreme Relief Dry Eye

Infection Risk:

The eye drops in question may contain bacteria that could lead to eye infections, potentially causing blindness. Although the FDA has not received reports of infections from consumers who used these products, they are advising manufacturers to remove potentially contaminated items from store shelves.

Previous Recalls:

This warning follows a series of eye drop recalls issued earlier in the year after it was discovered that some products were contaminated with a drug-resistant bacterium called Pseudomonas aeruginosa. These tainted eye drops were linked to at least four deaths and several infections across 18 states, according to data from the Centers for Disease Control and Prevention.

Consumer Reaction:

Consumer advocates have expressed frustration over the delayed discovery of this widespread problem and have called for the FDA to have more authority to recall unsafe prescription and over-the-counter medications when companies fail to cooperate promptly.

Teresa Murray, a consumer watchdog at U.S. PIRG Education Fund, expressed her indignation and said, “This is infuriating for a few reasons. First, prior to this FDA warning, there have been three major eye drop recalls this year for bacterial contamination or unsterile products. Why has it taken this long for the FDA to discover this much broader problem? Second, this points to the need for the FDA to have authority to recall unsafe prescriptions and over-the-counter medications when companies — for example, this eye drop manufacturer — refuse to cooperate in a timely fashion.”

FDA's Recommendations:

Consumers who have purchased any of the potentially contaminated eye drops are urged to discard them. If individuals suspect they have experienced adverse reactions to these lubricants, the FDA encourages them to report their concerns through the agency's MedWatch Adverse Event Reporting program.

The FDA's latest alert serves as a precautionary measure to protect consumers from potential health risks associated with these eye drop products.

"Your eye health is important, and we are dedicated to ensuring the safety and effectiveness of all products on the market. We encourage consumers to be vigilant and take prompt action to protect themselves if they have purchased any of the affected eye drops," said Dr. Janet Woodcock, the FDA's Acting Commissioner.

It is crucial for consumers to stay informed and heed the warnings issued by regulatory authorities to safeguard their health. In the case of eye drops, it is especially important to prioritize safety and opt for alternative products recommended by healthcare professionals until the contaminated batches are fully recalled and the manufacturing facility rectifies its sanitary conditions.

Remember, prevention is always better than cure, and taking proactive measures to protect your vision is essential. Stay informed, stay safe!

"Your eyesight is precious, so make sure to prioritize its protection. By staying informed and taking the necessary precautions, you can safeguard your vision and ensure long-term eye health."