In a significant public health announcement, the U.S. Food and Drug Administration (FDA) has cautioned consumers against purchasing and urged immediate cessation of use of 26 over-the-counter eye drop products. This warning stems from the potential risk of eye infections associated with these products, which could result in partial vision loss or even blindness. The FDA has identified specific brands that consumers should avoid:
- CVS Health
- Lubricant Eye Drops 15 ml (single pack)
- Lubricant Eye Drops 15 ml (twin pack)
- Lubricant Gel Drops 15 ml (single pack)
- Lubricant Gel Drops 15 ml (twin pack)
- Multi-Action Relief Drops 15 ml
- Lubricating Gel drops 10 ml
- Lubricant Eye Drops 10 ml (single pack)
- Lubricant Eye Drops 10 ml (twin pack)
- Mild Moderate Lubricating Eye Drops 15 ml (single pack)
- Rugby (Cardinal Health)
- Lubricating Tears Eye Drops 15 ml
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
- Leader (Cardinal Health)
- Dry Eye Relief 10 ml
- Lubricant Eye Drops 15 ml (single pack)
- Lubricant Eye Drops 15 ml (twin pack)
- Dry Eye Relief 15 ml
- Eye Irritation Relief 15 ml
- Rite Aid
- Lubricant Eye Drops 15 ml (twin pack)
- Lubricant Eye Drops 10 ml (twin pack)
- Gentle Lubricant Gel Eye Drops 15 ml
- Lubricant Gel Drops 15 ml
- Lubricating Gel Drops 10 ml
- Multi-Action Relief Drops 15 ml
- Target
- Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
- Up&Up Extreme Relief Dry Eye 15 ml (single pack)
- Up&Up Extreme Relief Dry Eye 30 ml (twin pack)
- Velocity Pharma LLC
- Lubricant Eye Drop 10 ml (triple pack)
These eye drop products are intended to be sterile, and the FDA has raised concerns about their safety. Ophthalmic drug products, which are applied directly to the eyes, pose a heightened risk of harm because they bypass some of the body’s natural defenses.
The FDA initiated a recommendation for the manufacturer of these products to recall all lots on October 25, 2023. This action followed findings by FDA investigators of unsanitary conditions in the manufacturing facility, along with positive bacterial test results from environmental sampling of critical drug production areas within the facility. To ensure public safety, the FDA strongly advises consumers to properly discard these products.
Retailers such as CVS, Rite Aid, and Target are taking immediate action by removing the affected products from their store shelves and websites. However, products under the Leader, Rugby, and Velocity brands may still be available for purchase in stores and online and should be avoided.
It is important to note that as of now, the FDA has not received any adverse event reports of eye infections associated with these products. Nevertheless, the agency encourages healthcare professionals and patients to report any adverse events or quality issues with medicines to the FDA’s MedWatch Adverse Event Reporting program.
To report an adverse event or quality problem, you can:
- Complete and submit the report online at Medwatch.
- Download and complete the reporting form, then submit it via fax at 1-800-FDA-0178.
In conclusion, the FDA’s warning serves as a crucial reminder of the potential risks associated with certain over-the-counter eye drops. Consumers are advised to exercise caution and discontinue use of the affected products immediately, seeking medical attention if they experience any signs or symptoms of an eye infection. Your eye health is of paramount importance, and being informed about product recalls and safety alerts is essential to protect your vision.
