Dr. Berne's MSM drops and Mist - recalled due to Bacterial & Fungal Contamination, USA

United States

Dr. Berne's Whole Health Products is voluntarily recalling all lots of MSM DROPS 5%,15% Solution, Dr. Berne's Organic Castor Oil Eye Drops and Dr. Berne's MSM MIST 15% Solution to the consumer level. FDA analysis has found one lot (lot 6786) of Dr. Berne's MSM DROPS 5% Solution to fail sterility with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne's is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne's Organic Castor Oil Eye Drops and Dr. Berne's MSM MIST 15% Solution. To date, Dr. Berne's has received 2 reports of adverse events related to this recall. These affected products were distributed through Dr. Berne's webstore. Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. These products are used as a lubricating eye drop and is packaged in 30 ml/1.014 oz. plastic bottles. The product Dr. Berne's Organic Castor Oil Eye Drops are packaged in 30 mL/1fl oz white plastic bottle; Dr. Berne's MSM MIST 15% Solution is packaged in 30mL/1.014 oz white bottle. Dr. Berne's is notifying its distributors and customers by e-mail and arranging for return of its MSM DROPS 5% and 15% Solution and Dr. Berne's Organic Castor Oil Eye Drops and Dr. Berne's MSM MIST 15% Solution. Consumers/distributors/retailers that have product which is being recalled should stop using and return to Sun Star Organics, 988 Main Street, Orange, CA 92867. Company name: Dr. Berne's Whole Health Products Brand name: Dr. Berne's Product recalled: MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% Solution Reason of the recall: Bacterial and Fungal Contamination FDA Recall date: August 26, 2023