The FDA has issued a warning to consumers to immediately stop the purchase and use of 27 over-the-counter (OTC) eye drop products due to a potential risk for eye infection.
Let’s take note: this is the third major eye drop recall this year (thus far). And by "major," we mean that there's been more than just those three .... just on a smaller scale.
First things first: which eye drops?
We’ll start with a topline view of the marketed brands included in the FDA alert:
- CVS Health
- Leader (Cardinal Health)
- Rugby Cardinal Health
- Rite Aid
- Target Up & Up
- Velocity Pharma
- Walmart
Now these actual product names.
Like we said, there’s 27... So get ready!
CVS Health
- Lubricant Eye Drops 15 ml (single pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
- Lubricant Eye Drops 15 ml (twin pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
- Lubricant Gel Drops 15 ml (single pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 1%
- Lubricant Gel Drops 15 ml (twin pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 1%
- Multi-Action Relief Drops 15 ml
- Active Ingredients: Polyvinyl Alcohol 0.5%, Povidone 0.6%, & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
- Lubricating Gel drops 10 ml
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
- Lubricant Eye Drops 10 ml (single pack)
- Active Ingredient: Propylene Glycol Eye Drops 0.6%
- Lubricant Eye Drops 10 ml (twin pack)
- Active Ingredient: Propylene Glycol Eye Drops 0.6%
- Mild Moderate Lubricating Eye Drops 15 ml (single pack)
- Active Ingredient: Polyethylene Glycol 400 Eye Drop '0.25%
Rugby (Cardinal Health)
- Lubricating Tears Eye Drops 15 ml
- Active Ingredients: Hypromellose 2910-0.3% & Dextran 70- 0.1% Eye Drops
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
- Active Ingredient: Polyvinyl Alcohol Eye Drops 1.4%
Leader (Cardinal Health)
- Dry Eye Relief 10 ml
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
- Lubricant Eye Drops 15 ml (single pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
- Lubricant Eye Drops 15 ml (twin pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
- Dry Eye Relief 15 ml
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 1%
- Eye Irritation Relief 15 ml
- Active Ingredients: Polyvinyl Alcohol 0.5%, Povidone 0.6%, & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Rite Aid
- Lubricant Eye Drops 15 ml (twin pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
- Lubricant Eye Drops 10 ml (twin pack)
- Active Ingredient: Propylene Glycol Eye Drops 0.6%
- Gentle Lubricant Gel Eye Drops 15 ml
- Active Ingredients: Hypromellose 0.3%, Glycerin 0.2%, and Dextran 70 0.1% Eye Drops
- Lubricant Gel Drops 15 ml
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 1%
- Lubricating Gel Drops 10 ml
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
- Multi-Action Relief Drops 15 ml
- Active Ingredients: Polyvinyl Alcohol 0.5%, Povidone 0.6%, & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Target
- Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
- Up&Up Extreme Relief Dry Eye 15 ml (single pack)
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
- Up&Up Extreme Relief Dry Eye 30 ml (twin pack)
- Active Ingredient: Carboxymethylcellulose Sodium Eye Drops 0.5%
Velocity Pharma LLC
- Lubricant Eye Drop 10 ml (triple pack)
- Active Ingredient: Propylene Glycol Eye Drops 0.6%
Walmart
- Equate Hydration PF Lubricant Eye Drop 10 ml
- Active Ingredients: Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
That totals 27 products—I thought only 26 eye drops were recalled.
Not anymore. While the FDA’s original October 27 warning alerted consumers of 26 eye drops, on October 30, 2023, the agency updated that number to 27 to include Walmart’s Equate Hydration PF Lubricant eye drops (listed above).
Gotcha. So what’s the risk for use?
Per the FDA, there is a potential for eye infections from these products that could lead to partial vision loss or blindness.
And how were these discovered?
Agency investigators uncovered unsanitary conditions in the products’ manufacturing facility as well as positive bacterial test results from an environmental sampling of critical drug production areas within the facility.
On October 25, 2023, the FDA recommended the manufacturer recall all product lots.
Any reports of adverse reactions?
As of October 30, nope.
However, the FDA stated that, “Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.”
The agency advises both health care professionals (HCPs) and patients to report any adverse events or quality problems to its MedWatch Adverse Event Reporting program.
Any other recommendations?
The American Optometric Association issued its own alert regarding the eye drop recall on October 31, noting that, when used and manufactured properly.
The organization, "recommends all patients consult with their local AOA optometrist before purchasing eye drops to ensure an appropriate treatment plan is in place."
When talking with a doctor of optometry, "it’s also important to share any prescribed and over-the-counter medications currently in use to avoid health complication," the AOA stated.
What’s the status of these products?
Per the FDA, Target, CVS, and Rite Aid have agreed to remove them from store shelves and online; however, “Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.”
Further, Walmart (the most recent add-on to this recall), is reported to also be removing its Equate Hydration eye drops from its shelves and website.
I could’ve sworn we just had a recall.
Oh yes, we did.
The most recent was in August 2023, when the FDA issued a warning against the use of two MSM eye drops (click here to see our coverage).
Earlier, in April 2023, the agency warned against the use of amniotic fluid eye drops manufactured by Regener-Eyes and M2 Biologics that were not FDA-approved (see here).
Edited to add: To note, no recall was actually initiated nor any adverse effects reported for the M2 Biologics or Regener-Eyes products.
Before that, in March 2023, Apotex Corp and Pharmedica USA initiated voluntary recalls of their eye drop solution products. Read about that here.
And, to kick off the year, in January 2023, the CDC called for an immediate discontinuation of EzriCare Artificial Tears (later followed by Delsam Pharma’s Artificial Tears and Artificial Eye Ointment) after reports of infections across the country.
The aftermath of that outbreak was significant:
- A total of 81 people affected in 18 states
- To date, 14 people went blind, four required enucleation, and four others died.
- A mass of lawsuits have trickled in.
Any other news?
Not yet. Stay tuned as this is a developing story.