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FDA Warns Against Use of Over 20 Eye Drop Brands Due to Contamination Risks
by Robert Dinga, O.D.

On October 27, 2023, the FDA issued a cautionary advisory regarding the use of numerous eye drop products available under various brand names. The FDA stated that these products may potentially harbor harmful bacteria, which can lead to eye infections, and in severe cases, may result in partial or complete vision loss.1 The FDA strongly recommended consumers discontinue the use of these eye drops and safely dispose of any remaining bottles.

Important Information:

  • Affected eye drops encompass brands distributed by prominent pharmacies and retailers such as CVS, Walgreens, Walmart, and Target.
  • Impacted brands include CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma.
  • Specific eye drop categories include lubricants, artificial tear solutions, redness relievers, and gel drops.
  • On October 25, 2023, the FDA urged the manufacturer to recall all batches due to unsanitary conditions discovered at the production facility.
  • Environmental samples collected at the facility tested positive for the presence of harmful bacteria.
  • CVS, Rite Aid, Target, and Walgreens have taken measures to remove the affected products from their shelves, but some may still be in circulation.

Potential Risks and Hazards:

The use of eye drops bypasses the body’s natural defense mechanisms, thereby posing significant health risks. As of now, the FDA has not received any reports of infections or adverse events related to these products. Nevertheless, the utilization of these eye drops has the potential to lead to eye infections, which, though rare, may result in vision impairment or blindness.

FDA Recommendations:

Consumers are strongly advised to immediately cease using these eye drops and dispose of them in a safe manner. It is recommended to refrain from purchasing eye drops bearing the affected brand names. Should you experience any symptoms of an eye infection after using these products, seek medical attention promptly. Report any adverse effects to the FDA through their MedWatch Adverse Event Reporting program. You can submit the completed form online via MedWatch or fax it to 1-800-FDA-0178. The FDA emphasized that this warning remains an ongoing concern, and consumers should regularly check the agency’s website for updates. Anyone experiencing eye discomfort or vision issues after using these eye drops should promptly consult a doctor or ophthalmologist. As of the time of this article’s publication, the FDA had not received any reports of eye infections resulting from the use of these products.

Please refer to the FDA.gov website for the most up-to-date list of impacted eye drops as of 10/30/2023 but the below list is complete as of the time of this article being published.

RETAILER/ LABEL PRODUCT PRODUCT INFORMATION
CVS Health Lubricant Eye Drops 15 ml (single pack) Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
Lubricant Eye Drops 15 ml (twin pack) Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
Lubricant Gel Drops 15 ml (single pack) Carboxymethylcellulose Sodium Eye Drops 1% w/v
Lubricant Gel Drops 15 ml (twin pack) Carboxymethylcellulose Sodium Eye Drops 1% 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 pack) Propylene Glycol Eye Drops 0.6% w/v
Lubricant Eye Drops 10 ml (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 pack) Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
Lubricant Eye Drops 15 ml (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
Walmart Equate Hydration PF Lubricant Eye Drop 10 ml Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
    1. U.S. Food & Drug Administration, 30 Oct 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. Accessed 1 Nov. 2023.
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author
Robert Dinga, O.D.
Robert Dinga, O.D.
Dr. Dinga is a clinical and operations executive with over 20 years of experience and a proven track record of success. Dr.…

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