Multiple eye drops and eye lubricant products have been recalled by the FDA in 2023.
While these recalls do not appear to be linked to one another, they suggest that manufacturers may be slacking on quality standards for their eye products, particularly within the online pharmaceutical market.
Eye drop manufacturer Dr. Berne’s voluntarily recalled its MSM Drops 5% and 15% Solution Eye Drops last week, following an August warning from the Food and Drug Administration (FDA) to avoid the drops due to bacterial and fungal contamination as well as the presence of methylsulfonylmethane (MSM), an unapproved and illegally marketed ingredient.
The news follows a slew of eye drop recalls and alerts this year—an unusual occurrence in the eye care industry. In most cases, products were nonsterile and/or contaminated by bacteria, fungus, or both.
“This is something we have not seen—especially to this degree—for quite some time,” says Benjamin Bert, MD, an ophthalmologist at MemorialCare Orange Coast Medical Center in Fountain Valley, CA.
In the same warning, the FDA urged consumers not to buy or use LightEyez’ MSM Eye Drops – Eye Repair due to bacterial and fungal contamination and unapproved, illegally marketed ingredients. According to the FDA, despite its attempts to contact LightEyez, the company has not responded or issued a voluntary recall of the product. Four deaths have been linked to the recent warning.
Unapproved and illegally marketed ingredients at play
Both the recalled Dr. Berne’s eyedrops and warned-against LightEyez eye drops contain MSM as an active ingredient. This ingredient is sometimes touted as a holistic health cure, Dr. Bert says. However, it is not approved for any medicinal—or legal— use in the US, and it may pose adverse health risks.
Are recalls connected?
Overall, eye drop outbreaks appear “fairly individual” and are not linked across companies, says Dr. Bert. However, he adds that some problems may be connected to and influenced by the growing online market for eye drops—where sellers do not always maintain the quality and safety standards customers are used to.
“It doesn't seem like there's a direct connection between any of these companies, but it is showing that the FDA is taking an even greater interest in investigating some of these smaller companies, a lot of which are selling their products online,” Dr. Bert says.
When it comes to FDA regulation to date, Dr. Bert says that online sales tend to make it “even more difficult for supervision and an oversight to protect consumers and patients.”.
Some recently recalled eye products include:
Dr. Berne’s MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% Solution
Company Dr. Berne’s Whole Health Products voluntarily recalled all lots of Dr. Berne’s MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops, and MSM MIST Drops 5% Solution this August due to non-sterility and bacteria and fungal contamination. According to the recall, use could lead to minor or serious adverse events, including life-threatening infections. So far, two adverse events have been reported.
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EzriCare, LLC and Delsam Pharma’s Artificial Tears Lubricant Eye Drops:
Company Global Pharma Healthcare voluntarily recalled this product in early February, citing “55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection,” according to the FDA. In a separate statement, the company warned of risks like blindness and infections.
Delsam Pharma’s Artificial Eye Ointment
Company Global Pharma also recalled one batch—Batch No. H29—of its Delsam Pharma Artificial Eye Ointment in late February due to “possible microbial contamination.” While no adverse events were reported with this batch, the company warned of potential risks, including eye infections that could lead to blindness.
Apotex Brimonidine Tartrate Ophthalmic Solution, 0.15%
Company Apotex Corp. voluntarily recalled six lots of Apotex’s Brimonidine Tartrate Ophthalmic Solution, 0.15%, this March due to cracks in bottles that could impact the product’s sterility and the possibility of adverse events. The lots had been distributed nationwide from April 5, 2022, to February 22, 2023, according to the FDA, and included lot numbers TJ9848, TJ9849, TK0258, TK5341, TK0261, and TK0262.
Pharmedica Purely Soothing, 15% MSM Drops
Company Pharmedica USA LLC voluntarily recalled two lots of its Purely Soothing, 15% MSM Drops this March due to nonsterility that could result in the risk of eye infections that could cause blindness. The recalled drops have dropper caps and white lids and include lot numbers 2203PS01, 1 oz; UPC 7 31034 91379 9; 1808051, ½ oz; and UPC 7 31034 91382 9.
Where to buy safe eye drops
It’s important for people not to purchase or use any of the recalled items—including LightEyez MSM Eye Drops Eye Repair—due to the FDA’s warning. However, Dr. Bert says that individuals do not need to avoid artificial tears and eye drops altogether. Because these instances don’t appear to be linked to one another, it should be safe to buy drops from other companies for which the FDA has not issued warnings or recalls, he says. Encouraging patients to shop in-person at a pharmacy and buy a known name brand is one way to increase the chances that their product is sterile and safe, he adds. Furthermore, there may be a silver lining in the recalls: The FDA is displaying interest in the online eye drop industry, which could lead to safer sales going forward.
“The most important thing to remember is that the major manufacturers and the major pharmaceutical companies have not had any contamination issues with any of their products during th[e] time of these recalls,” Dr. Bert says. “The easiest way to make sure that you're safe is to purchase from a pharmacy that is selling one of the major brand name medications. Those are the ones that are regulated fairly heavily and have not had any issues with contamination of their products,” he adds.
To help guide those purchasing eye drops at a pharmacy, physicians should tell their patients to examine the packaging and verify that the cap and other safety seals are in place—and to ask for guidance if they have questions.
People who experience adverse reactions to an eye product, regardless of the brand, should stop using it and reach out to a doctor, Dr. Bert says.
What this means for you
Multiple eye drop and lubricant products have been recalled by the FDA in 2023. Doctors should encourage patients to purchase known name brands of eye drops, and to reach out with questions or concerns about their products.