FDA Warns Consumers About Contaminated Eyedrops Containing Unapproved Drugs

The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers, urging them to immediately stop using certain brands of eyedrops due to potential contamination with bacteria and fungus.

The FDA has also highlighted the presence of unapproved drugs in these products.

Specifically, the contaminated eyedrops are “Dr. Berne’s MSM Drops 5% Solution” and “LightEyez MSM Eye Drops – Eye Repair,” which are distributed by Dr. Berne’s Whole Health Products and LightEyez Limited, respectively.

According to FDA officials, these contaminated eyedrops contain methylsulfonylmethane, or MSM, as an active ingredient.

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However, the use of MSM as an eye drug is unapproved in the United States, rendering the marketing of these products illegal. In addition, the FDA’s investigations have revealed a startling lack of sterility in these eyedrops, a violation of federal law that mandates sterile conditions for eye drop products.

“The health and safety of the American public are our top priorities. We will not tolerate the presence of unapproved drugs and potential contamination in medical products,” Dr. Janet Woodcock, Acting FDA Commissioner, said.

The FDA’s analysis further uncovered the presence of five distinct strains of bacteria across the two brands. Notably, the “Dr. Berne’s MSM Drops 5% Solution” also showed signs of fungal contamination.

In response to these concerning findings, the FDA is urging consumers who possess these eyedrops to immediately discontinue their use and properly dispose of them.

In addition, the agency advises potential buyers to refrain from purchasing these products. The ramifications of using contaminated eyedrops extend beyond mere inconvenience; they can lead to serious infections that jeopardize both the user’s eyesight and overall health.

Dr. Berne’s Whole Health Products has taken a proactive step by initiating a voluntary recall of all the affected products, including “Dr. Berne’s Organic Castor Oil Eye Drops” and “Dr. Berne’s MSM Mist 15% Solution.” However, the FDA has been unable to establish contact with LightEyez Limited, which has yet to address the safety concerns raised.

“We urge consumers to take these warnings seriously and protect their health by discontinuing use of the identified products,” emphasized Dr. Woodcock. “Any signs of infection or adverse reactions should be immediately reported to medical professionals.”