Eyedrops manufacturer recalls 2 dozen products sold at big retailers

A manufacturer of 27 different eyedrop products has issued a voluntary recall after the U.S. Food and Drug Administration said inspectors found unsanitary conditions at a manufacturing plant in India.
A manufacturer of 27 different eyedrop products has issued a voluntary recall after the U.S. Food and Drug Administration said inspectors found unsanitary conditions at a manufacturing plant in India. | Adobe.stock

The manufacturer of 27 different eyedrop products has issued a voluntary recall after the U.S. Food and Drug Administration said the eyedrops should not be used because inspectors found unsanitary conditions at the manufacturing plant in India. The eyedrops are sold under different brands at U.S. retailers, including CVS, Rite Aid, Target and Walmart stores, among others.

According to the notice from the manufacturer, Kilitch Healthcare India Limited, posted on the FDA website, the voluntary recall includes product lots with expiration dates that range from November 2023 to September 2025.

Per the release, “For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.”

CBS reported, “The FDA cited a ‘risk of eye infections that could result in partial vision loss or blindness’ in urging against use of the products in late October, with the agency saying its investigators found unsanitary conditions and ‘positive bacterial test results’ from areas of an unidentified manufacturing facility.”

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Many of the eyedrops have probably already been removed from store shelves, as some of the retailers earlier announced they are no longer selling them. But there’s some concern that consumers have the products at home. If so, the FDA says it’s important not to continue using them.

The eyedrops can be thrown away or returned to the place of purchase. The FDA said those with questions about the recall can contact  regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com.

As the Deseret News previously reported, the eyedrops subject to recall are:

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).

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.

Rugby (Cardinal Health)

  • Lubricating Tears Eye Drops 15 ml.

  • Polyvinyl Alcohol 1.4% Lubricating Eye 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

  • Lubricant Eye Drop 10 ml (triple pack).

Walmart

  • Equate Hydration PF Lubricant Eye Drop 10 ml.