Safety Report: 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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

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

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-bernes-whole-health-products-issues-voluntary-nationwide-recall-dr-bernes-msm-drops-5-and-15