FDA warns against the use of certain illegally marketed methylsulfonylmethane (MSM) eye drops due to contamination

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The US Food and Drug Administration (FDA) is warning consumers to cease use and not purchase Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.

According to the FDA,¹ using contaminated eye drops could result in a minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.

As of August 28, 2023, Dr. Berne's has received reports of 2 adverse events associated with the use of these eye drops and has initiated a voluntary recall of all lots of MSM Drops 5% and 15% Solution. The company has also issued a voluntary recall of Dr. Berne's Organic Castor Oil Eye Drops and MSM MIST 15% Solution at the consumer level.

Patients who have signs or symptoms of eye infection after use should consult their health care professional immediately.

The Dr. Berne’s and LightEyez eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. According to the FDA, these products are unapproved drugs and illegally marketed in the US. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient in the US.¹

The FDA conducted sampling and testing based on the product's intended use in the eyes, as well as because of the recent uptick in manufacturing issues with eye drops. According to the FDA, testing showed the products were contaminated with microbes and were not sterile. Analysis found lot 6786 of Dr. Berne's MSM Drops 5% Solution to fail sterility with both bacterial and fungal contamination.

Furthermore, the FDA identified bacillus bacterial contamination and exophiala fungal contamination in Dr. Berne’s MSM Drops. While the LightEyez MSM Eye Drops showed bacterial contamination from pseudomonas, mycobacterium, mycolicibacterium, and methylorubrum.¹

According to the FDA, LightEyez Limited has not responded to the FDA’s request for a discussion over the concerns and has taken no action regarding a recall.¹

August 28, 2023: Story updated to reflect new adverse events reported by Dr. Berne's as well as voluntary recall information and lot affected

References:

1. FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. FDA. Press Release. August 22, 2023. Accessed August 23, 2023.https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops