You might be tired of hearing about eye drop recalls, but the FDA has issued a new list of eye drops to stop using. This time, it includes store brand lubricant eye drops from Target, CVS, and Rite Aid. When we first wrote about these brands in October, the FDA had recommended a recall based on tests that revealed potential bacterial contamination. As of November 15, 2023, the manufacturer has officially recalled those eyedrops.
Which eye drops are affected?
The full list is here, and it includes eye drops made by one manufacturer and sold under several different brand names. If you have drops from these brands, check the exact name and package size against the FDA’s list. They include:
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CVS Health (lubricant eye drops, lubricant gel drops, multi-action relief drops, and mild moderate lubricating eye drops)
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Rugby/Cardinal Health (lubricating tears eye drops, polyvinyl alcohol 1.4% lubricating eye drops)
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Leader/Cardinal Health (dry eye relief, lubricant eye drops, eye irritation relief)
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Rite Aid (lubricant eye drops, gentle lubricant gel eye drops, lubricant gel drops, multi-action relief drops)
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Target Up & Up (dry eye relief lubricant eye drops, extreme relief dry eye)
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Velocity Pharma LLC (lubricant eye drops)
The recall applies to products with expiration dates from November 2023 to September 2025. Besides the FDA’s list above, you can also check this recall list from the manufacturer.
What is wrong with these eye drops?
Unlike the recall earlier this year, these eye drops have not (yet) been tied to specific cases of illness or death. The FDA found a potential risk of eye infections that could result in vision loss:
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.
If you have symptoms of an eye infection after using these drops, the FDA advises that you talk to your provider or seek medical care. Symptoms of infection may include pain, redness, itching, swelling, or new changes in your vision.
Is this related to other eye drop warnings and recalls?
This warning isn’t directly related to the previous ones this year, but it’s reasonable to assume that there is increased scrutiny on eye drop manufacturers after the deadly eye infection outbreak in early 2023. Here is a rundown of the major eye drop recalls and warnings this year:
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Earlier this year, the CDC and FDA worked together to track down the source of an outbreak of drug-resistant Pseudomonas aeruginosa infection. The bacteria in those infections were resistant to several different antibiotics, and there were 81 cases of these infections in 18 states. Four people died, four people had to have an eyeball removed, and 14 had vision loss. The products involved in that outbreak were EzriCare and Delsam Pharma artificial tears. The FDA warning about these products, initially issued in February 2023 and updated several times, is here.
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In March 2023, Apotex issued a recall of brimonidine tartrate eye drops because the caps on some of the bottles were breaking and could easily become contaminated.
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Also in March 2023, Pharmedica USA issued a recall of their MSM (methylsulfonylmethane) drops due to potential contamination.
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In August 2023, the FDA issued a warning about Dr. Berne’s and LightEyes MSM drops due to contamination by bacterial and fungal species.
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And in September, the FDA issued warning letters to the makers or manufacturers of eight brands of eye drops, including various products from Boiron, Similisan, CVS Health, Walgreens Boots Alliance, and others. Some of the products had “quality issues” in manufacturing that meant they couldn’t be relied upon to be sterile; some used silver, which can turn eyes and skin gray over time, a condition called argyria; and some were homeopathic, a category of “drug” based on a long-discredited theory. (The FDA tolerates homeopathic “drugs” being on the market, so long as they don’t pose a serious danger to users; these were deemed risky enough to be pulled.) Some brands had multiple issues, so again, check your specific products against those named in the warning letters.
