The U.S. Food and Drug Administration (FDA) has issued a recall alert for numerous ophthalmic products concerning potential eye infections that could lead to serious health issues, including partial vision loss or blindness. Cardinal Health Inc. has voluntarily recalled all lots of six Leader brand eye products, expanding their initial list to include a sixth item recently identified by the FDA. Furthermore, Harvard Drug Group LLC has initiated a recall for all lots of two Rugby Laboratories brand eye drops.
In a critical update, the FDA has added Equate Hydration PF Lubricant Eye Drop 10 mL, distributed by Walmart, to the list of products consumers are urged to avoid. Walmart has responded by pulling the product from physical shelves and online sales channels.
The recall initially released on October 27, 2023, now includes a total of 26 over-the-counter eye drop products across various brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
These products are supposed to be sterile, as non-sterility in products intended for ocular use can bypass some of the body's protective mechanisms and cause harm. The recall followed an FDA investigation that uncovered unsanitary conditions and positive bacterial contamination in the production areas of the manufacturing facility.
Retailers such as CVS, Rite Aid, and Target are actively removing the affected items from their stores and online platforms. However, there is a warning that some products under the Leader, Rugby, and Velocity brands may still be available for purchase and should be avoided by consumers.
Currently, the FDA has not received any reports of adverse events linked to these recalled products. Healthcare professionals and patients are encouraged to report any adverse events or quality issues related to these medicines to the FDA’s MedWatch Adverse Event Reporting program.
For a comprehensive list of the recalled eye drop products, including the national drug codes (NDCs), please see this chart provided by the FDA.
Eye Drop Retailers and Product Information
|
Retailer/ Label |
Product |
Product Information |
National Drug Code (NDC)* |
|---|---|---|---|
|
CVS Health |
Lubricant Eye Drops 15 ml (single pack) |
Carboxymethylcellulose Sodium 0.5% |
To be provided |
|
Lubricant Eye Drops 15 ml (twin pack) |
Carboxymethylcellulose Sodium 0.5% |
To be provided |
|
|
Lubricant Gel Drops 15 ml (single pack) |
Carboxymethylcellulose Sodium 1% |
To be provided |
|
|
Lubricant Gel Drops 15 ml (twin pack) |
Carboxymethylcellulose Sodium 1% |
To be provided |
|
|
Multi-Action Relief Drops 15 ml |
Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% |
To be provided |
|
|
Lubricating Gel drops 10 ml |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
To be provided |
|
|
Lubricant Eye Drops 10 ml (single pack) |
Propylene Glycol 0.6% |
To be provided |
|
|
Lubricant Eye Drops 10 ml (twin pack) |
Propylene Glycol 0.6% |
To be provided |
|
|
Mild Moderate Lubricating Eye Drops 15 ml (single pack) |
Polyethylene Glycol 400 0.25% |
To be provided |
|
|
Leader (Cardinal Health) |
Eye Irritation Relief 0.5 FL OZ (15 ml) |
Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% |
70000-0087-1 |
|
Dry Eye Relief 0.5 FL OZ (15 ml) |
Carboxymethylcellulose Sodium 1% |
70000-0089-1 |
|
|
Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) |
Carboxymethylcellulose Sodium 0.5% |
70000-0090-1 |
|
|
Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) |
Carboxymethylcellulose Sodium 0.5% |
70000-0090-2 (carton) 70000-0090-1 (bottle) |
|
|
Dry Eye Relief 0.33 FL OZ (10 ml) |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
70000-0088-1 |
|
|
Lubricant Eye Drops 0.33 FL OZ (10 ml) |
Polyethylene Glycol 0.6% |
70000-0587-1 |
|
|
Rugby (Harvard Drug Group) |
Lubricating Eye Drops 0.5 oz (15 ml) |
Polyvinyl Alcohol 1.4% |
0536-1325-94 |
|
Lubricating Tears Eye Drops 0.5 oz (15 ml) |
Dextran/Hypromellose 0.1%/0.3% |
0536-1282-94 |
|
|
Rite Aid |
Lubricant Eye Drops 15 ml (twin pack) |
Carboxymethylcellulose Sodium 0.5% |
To be provided |
|
Lubricant Eye Drops 10 ml (twin pack) |
Propylene Glycol 0.6% |
To be provided |
|
|
Gentle Lubricant Gel Eye Drops 15 ml |
Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% |
To be provided |
|
|
Lubricant Gel Drops 15 ml |
Carboxymethylcellulose Sodium 1% |
To be provided |
|
|
Lubricating Gel Drops 10 ml |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
To be provided |
|
|
Multi-Action Relief Drops 15 ml |
Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% |
To be provided |
|
|
Target |
Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
To be provided |
|
Up&Up Extreme Relief Dry Eye 15 ml (single pack) |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
To be provided |
|
|
Up&Up Extreme Relief Dry Eye 30 ml (twin pack) |
Carboxymethylcellulose Sodium 0.5% |
To be provided |
|
|
Velocity Pharma LLC |
Lubricant Eye Drop 10 ml (triple pack) |
Propylene Glycol 0.6% |
To be provided |
|
Walmart |
Equate Hydration PF Lubricant Eye Drop 10 mL |
Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% |
To be provided |
