FDA warning for eye drops usage: Reason, affected brands, and other details revealed

FDA issues warning upon usage of certain methylsulfonylmethane eye drops (Image via Yoshiyoshi Hirokawa / Getty Images)
FDA issues warning regarding usage of certain eye drops (Image via Yoshiyoshi Hirokawa / Getty Images)

The FDA has warned consumers against buying or using at least two methylsulfonylmethane (MSM) Eye Drops over fungal and/or bacterial contamination concerns. Consumers are advised to stop using LightEyez MSM Eye Drop – Eye Repair and Dr. Berne's MSM Drops 5% Solution immediately as they could cause serious health risks.

Announced on August 22, 20223, the nationwide warning and alert only applies to the two products mentioned above, which were distributed in and around the United States by LightEyez Limited and Dr. Berne's Whole Health Products. The contamination issue came to the FDA's notice when the federal agency conducted tests for the intended uses of the products.

As per the results, neither of the two were sterile and even contained microbes.

FDA advises people to stop using LightEyez and Dr. Berne’s eye drop products (Image via Hitoshi Nishimura / Getty Images)
FDA advises people to stop using LightEyez and Dr. Berne’s eye drop products (Image via Hitoshi Nishimura / Getty Images)

While the federal agency has not received any confirmed reports of infections or ill effects linked to the affected products, consumers who may have used them are advised to stay cautious. Using these products with fungal and/or bacterial contamination can cause people to catch major infections which can even become life-threatening.


Dr. Berne's Whole Health Products recalled its eye drops after the FDA warning

The United States Food and Drug Administration (FDA) has warned customers to stop buying and using all methylsulfonylmethane (MSM) eye drop products, including LightEyez MSM Eye Drops – Eye Repair and Dr. Berne's MSM Drops 5% Solution. Reported to be affected by fungal and/or bacterial contamination, the products may cause serious to life-threatening health risks.

ProductBacterial ContaminationFungal Contamination
Dr. Berne’s MSM Drops 5% Solution Bacillus, spp. Exophiala, sp.
LightEyez MSM Eye Drops – Eye Repair Pseudomonas, spp

Mycobacterium, spp

Mycolicibacterium, spp

Methylorubrum, spp
N/A

LightEyez and Dr. Berne's eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. It is important to note that the FDA has not approved the use of MSM in eye drops.

Companies are also not allowed to sell products containing methylsulfonylmethane in the United States.

“These products are unapproved drugs and illegally marketed in the U.S.," the FDA said.

Following the FDA's warning, Dr. Berne's Whole Health Products agreed to recall Dr. Berne's MSM Drops 5% Solution. The establishment further issued a voluntary recall notice this week on August 26, which affects - MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops, and MSM MIST Drops 5% Solution.

Dr. Berne's Whole Health Products recalled the contaminated eye drop products this week (Image via Yoshiyoshi Hirokawa / Getty Images)
Dr. Berne's Whole Health Products recalled the contaminated eye drop products this week (Image via Yoshiyoshi Hirokawa / Getty Images)

However, LightEyez Limited has not responded or taken any action regarding the contaminated products as of this writing. Either way, consumers are advised not to use the above-mentioned products anymore. Individuals who may have already used them and are facing issues with their eyes should visit a medical professional at the earliest.

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Edited by Adelle Fernandes
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