Alert: Nationwide Recall of Popular Eye Drops – Here’s What You Need to Know

FDA Recall - Eye Care Safety

In a significant health alert, the FDA has issued a warning and subsequent recalls for several major brands of eye drops. This action comes in response to the discovery of insanitary conditions and bacterial contamination in the manufacturing facilities. The affected products include six varieties of Leader brand ophthalmic products from Cardinal Health Inc., two types of Rugby Laboratories eye drops from Harvard Drug Group LLC, and Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart.

 

Retailer/Label Product Name Product Information 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%, 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%, 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%, 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

 

These eye drops, intended to be sterile, bypass some of the body’s natural defenses, making the risk of harm from contamination particularly high. The FDA’s decision to recommend the recall of all lots of these products was made on October 25, 2023, after agency investigators found concerning conditions and test results. As of now, no reports of eye infections linked to these products have been received by the FDA. However, the agency is taking a proactive approach to prevent potential health risks.

At Compton Eye Associates, we are committed to ensuring the safety and well-being of our patients. We closely monitor such health updates and take immediate action to adjust our recommendations and prescriptions accordingly. Our team is dedicated to providing the most current and safe eye care options.

We encourage our patients to remain vigilant and informed. If you have used any of these recalled products and are concerned about your eye health, please do not hesitate to contact us at 800-936-0036. Alternatively, you can schedule an appointment for a comprehensive consultation. At Compton Eye Associates, your eye health is our top priority, and we are here to assist you with the most up-to-date and accurate information

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