More Eyedrops Recalled Due to Bacterial, Fungal Contamination

On August 22, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers on two methylsulfonylmethane (MSM) eyedrops, reporting bacterial and fungal contaminations as the primary cause.

The warnings apply to Dr. Berne’s MSM Drops 5% olution and LightEyez MSM Eye Drops – Eye Repair drops. Berne’s MSM drops have been contaminated with Bacillus spp, and Exophiala sp. Meanwhile, The LightEyez MSM eyedrops have not had any detectable fungal contamination but have been linked to Pseudomonas spp., Mycobacterium spp., Mycolicibacterium spp., and Methylorubrum spp. contamination.

According to the warning letter, the FDA sampled and tested these products as a precaution due to recent eyedrop recalls earlier this year. On February 2, 2023, the first of several eyedrop recalls was issued by Global Pharma Healthcare for Pseudomonas aeruginosa contamination in their artificial tears.

The investigation began when the CDC identified multiple cases of drug-resistant bacterial infections linked across four healthcare systems in 12 states. Initially, conditions were identified in 55 individuals, dating back to May 2022. Investigations and testing linked the contamination to EzriCare LLC and Deslam Pharma artificial tears, which Global Pharma Healthcare manufactures.

Shortly after the initial recall, the FDA announced recalls of two additional eye drops, including Brimonidine Tartrate Ophthalmic Solution, manufactured by Apotex Corp., and Purely Soothing, 15% MSM drops, by Pharmedica USA LLC.

Understanding the complex sterility issues and existing recalls, the FDA has been monitoring the industry. “FDA conducted sampling and testing based on these products’ intended use in the eyesand due to the industry’s recent manufacturing issues with eye drops. FDA’s testing showed the products were contaminated with microbes and were not sterile. Under the Federal Food, Drug, and Cosmetic Act, eye drops must be sterile to be safe for use,” noted the press release.

While Dr. Berne entered a verbal agreement with the FDA on August 21, 2023, to recall their products, LightEyez has not responded to the FDA’s email highlighting concerns.

Although the FDA is not authorized to issue recalls, the administration warns consumers to avoid these products. In addition, consumers can minimize their risk by practicing good hygiene when applying eye drops or opting for single-use vials.