Update: Dr. Berne’s MSM Eye Drops Are Voluntarily Recalled

After the US Food and Drug Administration issued warnings to stop using and discard Dr. Berne’s MSM Drops 5% Solution on August 24, 2023, Dr. Berne’s Whole Health Products has voluntarily recalled MSM Drops 5%, 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution. All lots for all products are being recalled.

According to the risk statement: “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.”

Dr. Berne's webstore distributed Dr. Berne's Organic Castor Oil Eye Drops and Dr. Berne's MSM MIST 15% Solution, both packaged in 30mL/1fl oz white plastic bottles, used as lubricating eye drops.

As Infection Control Today® reported, some of the contamination of the Dr. Berne’s MSM Drops 5% Solution were Bacillus, spp. and Exophiala, spp.

The FDA discovered contamination in recent batches of eye drops during testing, which violates the Federal Food, Drug and Cosmetic Act that requires eye drops to be sterile for safe use.

The eye drop products from Dr. Berne contain the unapproved active ingredient, methylsulfonylmethane (MSM), and lack sterility. No ophthalmic drugs with MSM are legally marketed in the US.

Prior to this recall, the FDA warned against using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops—Eye Repair due to bacterial and fungal contamination. FDA notified LightEyez Limited of contaminated products on August 21, 2023, but received no response. Additionally, the company has not taken action to protect consumers from using the contaminated eye drops, according to the FDA.