FDA Warns Against Eye Drops from Major Brands Due to Infection Risk

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has warned consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products, including those from CVS, Target, and Rite Aid, due to the potential risk of eye infection leading to partial vision loss or blindness.¹

Announced on October 27, 2023, the agency recommended the manufacturers recall all lots on October 25, 2023, after agency investigators found unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas.

At the time of the announcement, the FDA noted it had not received any adverse event reports of eye infection associated with these ophthalmic products. Intended to be sterile, the agency indicated eye drops can present a higher risk of harm to users, as ophthalmic products bypass many of the human body’s natural defenses.

In September, the FDA similarly circulated warning letters to eight companies, including CVS Health and Walgreens, for manufacturing unapproved ophthalmic drug products in violation of federal law.² In February, the FDA urged the immediate discontinuation of EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears, due to potential bacterial contamination.³

Products from CVS, Rite Aid, and Target were among those removed from store shelves and websites, according to the release.¹ Products branded as Leader, Rugby, and Velocity may still be available in stores and online, but should not be purchased by consumers.

The complete list of companies and marketed products includes:

CVS Health

• _{Lubricant Eye Drops 15 ml (single/twin pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v)}
• _{Lubricant Gel Drops 15 ml (single/twin pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v)}
• _{Multi-Action Relief Drops 15 ml (Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops)}
• _{Lubricating Gel drops 10 ml (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)}
• _{Lubricant Eye Drops 10 ml (single/twin pack) (Propylene Glycol Eye Drops 0.6% w/v)}
• _{Mild Moderate Lubricating Eye Drops 15 ml (single pack) (Polyethylene Glycol 400 Eye Drop '0.25% w/v)}

Rugby (Cardinal Health)

• _{Lubricating Tears Eye Drops 15 ml (Hypromellose 2910-0.3% w/v & Dextran 70- 0.1% Eye Drops)}
• _{Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml (Polyvinyl Alcohol Eye Drops 1.4% w/v)}

Leader (Cardinal Health)

• _{Dry Eye Relief 10 ml (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)}
• _{Lubricant Eye Drops 15 ml (single/twin pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v)}
• _{Dry Eye Relief 15 ml (Carboxymethylcellulose Sodium Eye Drops 1% w/v)}
• _{Eye Irritation Relief 15 ml (Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops)}

Rite Aid

• _{Lubricant Eye Drops 15 ml (twin pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v)}
• _{Lubricant Eye Drops 10 ml (twin pack) (Propylene Glycol Eye Drops 0.6% w/v)}
• _{Gentle Lubricant Gel Eye Drops 15 ml (Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops)}
• _{Lubricant Gel Drops 15 ml (Carboxymethylcellulose Sodium Eye Drops 1% w/v)}
• _{Lubricating Gel Drops 10 ml (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)}
• _{Multi-Action Relief Drops 15 ml (Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops)}

Target

• _{Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)}
• _{Up&Up Extreme Relief Dry Eye 15 ml (single pack) (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)}
• _{Up&Up Extreme Relief Dry Eye 30 ml (twin pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v)}

Velocity Pharma LLC

• _{Lubricant Eye Drop 10 ml (triple pack) (Propylene Glycol Eye Drops 0.6% w/v)}

The FDA recommends consumers properly and promptly discard these products at a drop off of the medication at a drug take-back site or program. If there are no available take-back options, the agency suggests checking the FDA "Flush List" to see if the medication can be safely discarded at home.⁴

Those who have signs or symptoms of eye infection after the use of these drops were encouraged to talk to their healthcare provider or seek immediate medical care.¹ Healthcare professionals were urged to report any adverse events or quality problems with any medicine to the FDA’s MedWatch Adverse Event Reporting program.

References

1. _{Center for Drug Evaluation and Research. CDER alert. U.S. Food and Drug Administration. October 27, 2023. Accessed October 30, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye#eyedrops.}
2. _{Iapoce C. CVS, Walgreens among companies to receive FDA warning for marketing unapproved eye drops. HCP Live. September 12, 2023. Accessed October 30, 2023. https://www.hcplive.com/view/cvs-walgreens-among-companies-to-receive-fda-warning-for-marketing-unapproved-eye-drops.}
3. _{Iapoce C. FDA joins CDC, issues warning over EzriCare artificial tears. HCP Live. February 3, 2023. Accessed October 30, 2023. https://www.hcplive.com/view/cdc-issues-health-advisory-infection-outbreak-related-artificial-tears.}
4. _{Center for Drug Evaluation and Research. Disposal of unused medicines: What you should know. U.S. Food and Drug Administration. October 1, 2020. Accessed October 30, 2023. https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know.}