Kilitch Healthcare India’s voluntary recall of multiple US eye drop brands due to vision loss and blindness risks, flagged by the FDA, highlights grave concerns. Identified as contaminated, these over-the-counter eye drops pose serious health threats, prompting urgent cessation of use and product returns.
Kilitch Healthcare India Limited has initiated a voluntary recall of several over-the-counter lubricant eye drops in the United States. These products, marketed under popular brands such as Target, Rite Aid, CVS Health, Walmart, Rugby, Leader (Cardinal Health), and Velocity, have raised concerns due to potential risks associated with vision loss and blindness.
The recall, activated on November 13 by Kilitch Healthcare India, was officially announced by the Food and Drug Administration (FDA) on November 15. The affected eye drops encompass batches with expiration dates spanning from November 2023 to September 2025.
The USFDA highlighted that individuals using Kilitch Healthcare’s eye drop products may face a heightened risk of eye infections or related harm. These products, designed to be sterile, pose a potential threat to users as ophthalmic drug applications bypass some of the body’s natural defenses, as stated by the regulatory body.
Urgent measures have been advised by the FDA, directing distributors and retailers to halt the distribution of the recalled products. Consumers have been strongly urged to discontinue using the affected eye drops and are encouraged to return them to the point of purchase.
The USFDA has explicitly warned against the use of these products due to the severe risk of vision impairment or even complete blindness.
The FDA’s actions stem from its recommendation to the manufacturer on October 25, 2023, following the discovery of unsanitary conditions in the manufacturing facility. Moreover, positive bacterial test results from environmental sampling in critical drug production areas further supported the recall. The FDA emphasizes the proper disposal of these products to avoid potential harm.
On October 27, the USFDA issued a public warning advising against the purchase and immediate cessation of using 26 over-the-counter eye drop products. These products, previously available under various brands like CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma, pose risks of eye infections that could lead to partial vision loss or even blindness. Individuals experiencing signs or symptoms of eye infection after the use of these products are urged to seek medical attention promptly.
Several major retailers, including CVS, Rite Aid, and Target, have taken swift action by removing these identified products from their shelves and online platforms. However, cautionary advice from the regulator persists against the purchase of products branded Leader, Rugby, and Velocity, emphasizing their potential health risks.
An investigative report by Bloomberg revealed that the USFDA had cautioned consumers against purchasing or using store-brand eye drops from major retailers like Walmart Inc., CVS Health Corp., and Target Corp. due to the risk of eye infections. However, the manufacturer, Kilitch, was not initially named in these public warnings.
Bloomberg’s report highlighted concerning practices at Kilitch’s manufacturing facility in India, citing unsanitary conditions where some workers operated barefoot, and others allegedly manipulated test results to create an illusion of product safety.
For consumers’ reference, here is a list of affected eye drop products distributed under various brands:
- CVS Health Lubricant Eye Drops 15 ml (single pack)
- CVS Health Lubricant Eye Drops 15 ml (twin pack)
- CVS Health Lubricant Gel Drops 15 ml (single pack)
- CVS Health Lubricant Gel Drops 15 ml (twin pack)
- CVS Health Multi-Action Relief Drops 15 ml
- CVS Health Lubricant Gel drops 10 ml
- CVS Health Lubricant Eye Drops 10 ml (single pack)
- CVS Health Lubricant Eye Drops 10 ml (twin pack)
- CVS Health Mild Moderate Lubricating Eye Drops 15 ml (single pack)
- Leader (Cardinal Health) Eye Irritation Relief 0.5 FL OZ (15 ml)
- Leader (Cardinal Health) Dry Eye Relief 0.5 FL OZ (15 ml)
- Leader (Cardinal Health) Lubricant Eye Drops 0.5 FL OZ (15 ml) (single)
- Leader (Cardinal Health) Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack)
- Leader (Cardinal Health) Dry Eye Relief 0.33 FL OZ (10 ml)
- Leader (Cardinal Health) Lubricant Eye Drops 0.33 FL OZ (10 ml)
- Rugby (Harvard Drug Group) Lubricating Eye Drops 0.5 oz (15 ml)
- Rugby (Harvard Drug Group) Lubricating Tears Eye Drops 0.5 oz (15 ml)
- Rite Aid Lubricant Eye Drops 15 ml (twin pack)
- Rite Aid Lubricant Eye Drops 10 ml (twin pack)
- Rite Aid Gentle Lubricant Gel Eye Drops 15 ml
- Rite Aid Lubricant Gel Drops 15 ml
- Rite Aid Lubricating Gel Drops 10 ml
- Rite Aid Multi-Action Relief Drops 15 ml
- Target Up&Up Dry Eye Relief 15 ml
- Target Up&Up High-Performance Lubricant Eye Drops 15 ml (single pack)
- Target Up&Up High-Performance Lubricant Eye Drops 15 ml (twin pack)
- Velocity Pharma LLC Lubricant Eye Drop 10 ml (triple pack)
- Walmart Equate Hydration PF Lubricant Eye Drop 10 mL
In light of these developments, consumers are strongly advised to check the provided list against any eye drop products purchased recently and cease their usage if any match is found. Immediate return or proper disposal is recommended by FDA directives.
The recall of these eye drops by Kilitch Healthcare India in the US serves as a reminder of the critical importance of product safety and regulatory oversight to protect consumer well-being.
Kilitch Healthcare India’s recall reveals significant safety gaps in over-the-counter eye drops distributed in the US. The FDA’s stringent warnings about potential vision-related risks emphasize the paramount importance of rigorous manufacturing standards and regulatory oversight in safeguarding public health. Immediate discontinuation and return of the affected products are vital to prevent severe eye complications.
