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FDA Warns Against Using Contaminated Eye Drops

Testing finds bacteria and fungus


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Courtesy Dr Berne's/Getty Images/Courtesy LightEyez

The Food and Drug Administration has warned consumers not to purchase or use two brands of eye drops that it found to be contaminated with bacteria, fungus or both.

Testing found that Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair were contaminated with microbes and are not sterile or safe to use.

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The products were sold online by retailers like Amazon and contain an FDA-unapproved and illegal chemical methylsulfonylmethane (MSM). The substance is found naturally in humans, certain plants and animals. It’s purported to enhance nutrient absorption and eye circulation when used in eye drops.

The FDA is aware of two adverse events associated with Dr. Berne's products. Patients who have symptoms of an eye infection should talk to their health care provider immediately, the agency advised.

Dr. Berne agreed to voluntarily recall all lots of the 5% and 15% strengths of MSM Solution, all lots of Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution. The FDA is waiting for a response from LightEyez about its concerns.

Additional questions should be directed to Dr. Berne’s Whole Health Products at 877-239-3777, 9 a.m. to 5 p.m. Mountain time on weekdays, or by e-mail at hello@drsamberne.com.

Anyone who has any of these products should stop using them and send a return to Sun Star Organics, 988 Main St., Orange, CA 92867.

Dr. Berne’s MSM Drops 5% Solution were found to be contaminated with the bacteria, bacillus and the fungus, exophiala.

Meanwhile, LightEyez MSM Eye Drops – Eye Repair was found to be contaminated with the bacteria pseudomonas, mycobacterium, mycolicibacterium, and methylorubrum.

Any adverse events or quality problems with any medication should be submitted to the FDA's MedWatch Adverse Event Reporting program online at MedWatch or by faxing this form to 1-800-FDA-0178.

Several other brands of eye drops have been recalled this year over contamination concerns; the cause was that were later discovered at the manufacturer. The issue resulted resulting in infections that caused at least 14 people to lose their vision.

Editor's note: This story, originally published Aug. 25, 2023, has been updated to reflect new information.

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