Buzz
While eye drop recalls may be a familiar topic by now, the FDA has once again released a new warning list of eye drops to discontinue use. This recall now includes lubricant eye drops sold under store brands at Target, CVS, and Rite Aid. Initially, in October, the FDA had advised a recall after tests detected possible bacterial contamination. By November 15, 2023, the manufacturer officially recalled these eye drops.
Which brands of eye drops are impacted?
The comprehensive list is available here, including eye drops from one manufacturer sold under multiple brand names. If you have any of these drops, be sure to check the specific name and package size against the FDA’s list. A few of the affected brands include:
CVS Health (lubricant eye drops, gel drops for lubrication, multi-action relief eye drops, and mild to moderate lubricating eye drops)
Rugby/Cardinal Health (lubricating tear eye drops, polyvinyl alcohol 1.4% lubricating eye drops)
Leader/Cardinal Health (dry eye relief drops, lubricant eye drops, drops for eye irritation relief)
Rite Aid (lubricant eye drops, gentle lubricant gel drops, gel drops for lubrication, multi-action relief eye drops)
Target Up & Up (lubricant eye drops for dry eye relief, extreme relief for dry eyes)
Velocity Pharma LLC (lubricant eye drops)
The recall affects products with expiration dates ranging from November 2023 to September 2025. In addition to the FDA's official list, you can also refer to this recall list from the manufacturer for more details.
What’s the issue with these eye drops?
Unlike the earlier recall this year, no specific cases of illness or death have been directly linked to these eye drops. However, the FDA has identified a potential risk of eye infections that could lead to vision loss:
The FDA urged the manufacturer of these products to recall all affected lots on October 25, 2023, after its investigators discovered unsanitary conditions in the manufacturing facility, along with positive bacterial test results from environmental samples taken from critical areas in the production facility. The FDA also advises consumers to safely dispose of these products.
If you experience symptoms of an eye infection after using these drops, the FDA recommends that you consult your healthcare provider or seek medical attention. Infection symptoms may include pain, redness, itching, swelling, or noticeable changes in your vision.
Is this linked to previous eye drop warnings and recalls?
Although this warning isn’t directly connected to earlier ones from this year, it’s likely that eye drop manufacturers are under heightened scrutiny following the deadly eye infection outbreak in early 2023. Here’s a summary of the key eye drop recalls and warnings this year:
Earlier this year, the CDC and FDA collaborated to trace the source of an outbreak of drug-resistant Pseudomonas aeruginosa infections. These bacteria were resistant to multiple antibiotics, resulting in 81 cases across 18 states. Four people died, four others had to have an eyeball removed, and 14 suffered vision loss. The affected products were EzriCare and Delsam Pharma artificial tears. The FDA warning regarding these products, first issued in February 2023 and updated several times, is available here.
In March 2023, Apotex recalled brimonidine tartrate eye drops after discovering that the caps on some bottles were breaking, potentially leading to contamination.
Also in March 2023, Pharmedica USA recalled their MSM (methylsulfonylmethane) drops due to possible contamination.
In August 2023, the FDA issued a warning regarding Dr. Berne’s and LightEyes MSM drops due to contamination with bacterial and fungal species.
In September 2023, the FDA issued warning letters to the makers or manufacturers of eight eye drop brands, including products from Boiron, Similisan, CVS Health, Walgreens Boots Alliance, and others. Some of the products had manufacturing “quality issues” that made them unreliable in terms of sterility; others contained silver, which can cause eyes and skin to turn gray over time (a condition known as argyria); and some were homeopathic, which is based on a long-debunked theory. While the FDA allows homeopathic “drugs” to remain on the market as long as they do not pose a significant risk, these products were deemed dangerous enough to be pulled. Some brands had multiple issues, so it’s important to check your specific products against those named in the warning letters.
