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On October 27, 2023, the Food and Drug Administration (FDA) issued a cautionary alert to consumers, urging them to refrain from acquiring and discontinue the use of 26 different over-the-counter eye drop products.
On October 27, 2023, the Food and Drug Administration (FDA) issued a cautionary alert to consumers, urging them to refrain from acquiring and discontinue the use of 26 different over-the-counter eye drop products. These products carry a potential risk of causing eye infections, which, in severe cases, could lead to partial vision impairment or even blindness. Individuals who exhibit any signs or symptoms of an eye infection subsequent to using these products are advised to promptly consult with a healthcare professional or seek immediate medical attention. The affected eye drops are commercially available under the following brand names:
It is important to note that these products are specifically designed to be sterile. Ophthalmic drug products possess an elevated potential for harm to users because drugs applied to the eyes bypass some of the body’s natural defense mechanisms.
The FDA, on October 25, 2023, recommended the manufacturer of these eye drop products to initiate a comprehensive recall of all batches. This directive followed an inspection by FDA investigators, during which unsanitary conditions were identified within the manufacturing facility. Furthermore, critical drug production areas in the facility yielded positive bacterial test results from environmental sampling. The FDA also advises consumers to properly dispose of these products.
In response to the FDA’s announcement, CVS, Rite Aid, and Target have taken steps to remove these products from their store shelves and online platforms. Nevertheless, eye drops under the Leader, Rugby, and Velocity brands may still be available for purchase both in physical stores and online; however, it is strongly discouraged to acquire them.
| 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 |
As of the present moment, the FDA has not received any reports of adverse events related to eye infections associated with the use of these products. According to the FDA, they encourage both healthcare professionals and patients to promptly report any adverse events or quality issues concerning any medication through the FDA’s MedWatch Adverse Event Reporting program. This can be done by either completing and submitting the report online via MedWatch or by downloading and filling out the form and subsequently submitting it via fax at 1-800-FDA-0178.
The LASIK.com network has confirmed that it has not distributed any of the eye drop products mentioned in the FDA’s recent warning. This network ensures the safety and quality of the products it offers and is committed to upholding the highest standards of eye care. Patients and individuals seeking vision correction through LASIK procedures can rest assured that their services have not been associated with the distribution of the affected eye drops. If you have any questions please contact your local LASIK.com network center or doctor.
