Eye Drop Recall Expanded Due to Bacteria, Fungus Contamination

Dr. Berne's Whole Health is recalling additional eye drops after the FDA found contamination in that brand as well as LightEyez, which has not issued a recall

A recall of eye drops has been expanded after the Food and Drug Administration announced last week that it had found bacteria and fungus in two brands of eye drops.

The FDA issued a warning on August 22 against using two brands of eye drops — Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops — due to contamination.

However, only Dr. Berne’s Whole Health Products voluntarily recalled the line of products mentioned in the FDA’s statement. And on Tuesday, they announced a recall of all eye drop products — even though a statement from Dr. Berne says testing has shown the products to be uncontaminated.

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“The FDA has done a random investigation on one of my products, the 5% MSM Lot #6786.  They found microbial growth in the sample they tested. Both the FDA and I recommend a recall on all MSM and Castor Oil products. Please discontinue using all unexpired products that you may have on hand.”

The statement continues, “We have sample tested all our products with a 3rd party lab and will be publishing the findings on our site soon. All have come back with no microbial growth.”

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LightEyez, however, is still offering the eye drops on its website — and the FDA said that the company did not respond to communication, nor has it  “taken action to protect consumers.” In fact, a recall does not mean the company is required to take them off the market.

Contamination isn't the only issue with the drops, the FDA said. While MSM is a “naturally occurring organosulfur compound” that can aid in inflammation in the body, according to the National Institute of Health, the FDA says the inclusion in eye drops is illegal.

“The Dr. Berne’s and LightEyez eye drop products also contain methylsulfonylmethane (MSM) as an active ingredient,” the FDA said. “These products are unapproved drugs and illegally marketed in the U.S. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.”

“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” the FDA cautioned.

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The FDA found that Dr. Berne’s drops contained bacillus, which the CDC defines as a “major pathogen,” and exophiala, which the National Institute of Health calls an “opportunistic” fungus — and the company has received two reports of “adverse events” related to this recall.

LightEyez contained pseudomonas bacteria, which the CDC says is developing antibiotic resistance, and three other types of bacteria.

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