Tag: Food and Drug Administration

The Food and Drug Administration (FDA) has issued a warning, urging you not to buy and immediately discontinue the use of 27 over-the-counter eye drop products. It comes as a result of the potential risk of eye infections that could ultimately lead to partial vision loss or even blindness.

If you’ve used any of these products and are experiencing signs or symptoms of an eye infection, it’s important to consult your health care provider or seek immediate medical attention.

Eye drop recall

Impacted products are available under various brand names, which include CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma.

The problem: They are designed to be sterile, but ophthalmic drug products carry a heightened risk of harm due to the fact that drugs applied to the eyes bypass some of the body’s natural defense mechanisms.

On Oct. 25, 2023, the FDA recommended that the manufacturer of these products recall all lots from the market. That was after FDA investigators discovered unsanitary conditions in the manufacturing facility, as well as positive bacterial test results from environmental sampling of critical drug production areas within the facility. The FDA suggests properly disposing of these products ASAP.

CVS, Rite Aid and Target have already taken action to remove these potentially harmful products from their shelves and online platforms. However, it’s worth noting that products branded as Leader, Rugby and Velocity may still be available for purchase in physical stores and online, but they should be avoided.

List of impacted eye drops

Here is the list of eye drops to avoid and which retailers/labels to watch for:

• 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)
• Walmart:
  • Equate Hydration PF Lubricant Eye Drop 10 ml

NOTE: FDA has not received any adverse event reports of eye infection associated with these products at this time.

FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program. You can complete and submit the report online at MedWatch or download and complete the form, then submit it via fax at 1-800-FDA-0178.