Dr. Berne’s Whole Health Products voluntarily recalled more eyedrops during an ongoing FDA recall of one of its eyedrops solutions, the FDA announced today. The initial FDA recall was prompted by bacterial and fungal contamination of one Dr. Berne’s eyedrops solutions, and the threat to consumers’ eye health is a real one. According to the FDA, “using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”
The FDA initially recalled Dr. Berne’s MSM Drops 5% Solution, as well as LightEyez MSM Eye Drops – Eye Repair, on August 22, after the agency found bacterial and fungal contaminants in the Dr. Berne’s product and bacterial contaminants in the LightEyez product. Today, Dr. Berne’s voluntarily recalled several additional products: Dr. Berne’s MSM Drops 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution.
The FDA found contaminants in only one lot of MSM Drops 5% (lot 6786) so far, but Dr. Berne’s is recalling the other products “out of an abundance of caution,” the FDA reports. As of today, the agency notes that Dr. Berne’s has received two reports of adverse health events related to the recall.
Anyone with signs or symptoms of an eye infection should seek medical care immediately and report it to the FDA’s MedWatch Adverse Event Reporting program. Per the Cleveland Clinic, symptoms of an eye infection can include redness in the eye, itching, irritation, eye pain, watery eyes, and swelling.
Beyond the contamination, the Dr. Berne’s and LightEyez products also contain an active ingredient that’s not approved for use in eye products in the US: methylsulfonylmethane, or MSM. According to the FDA, that makes these products unapproved drugs that have been “illegally marketed in the US.” MSM is commonly used as an anti-inflammatory agent, per the National Institutes of Health (NIH), and can be used to treat osteoarthritis and rheumatoid arthritis but may cause “mild skin and eye irritation” when applied topically. Other side effects of MSM can include nausea, diarrhea, and headaches.
If you have a recalled Dr. Berne’s product, stop using it and return it to Sun Star Organics, 988 Main Street, Orange, CA 92867, the FDA says. If you’re unable to return the product, you can also dispose of it using the FDA’s drug disposal guidelines, which includes mixing the eyedrops with an unpalatable substance (think dirt, cat litter, used coffee grounds), sealing the mixture in a plastic bag, and throwing it away.
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