Contaminated Eye Drops Recalled

Concerns of bacterial and fungal contamination have prompted the recall of more than 6000 bottles of Dr Berne’s MSM Drops 15% Solution. The recall was included in the October 11, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes Dr Berne’s MSM Drops 15% Solution, in 30-mL/1.014-ounce bottles (UPC 00854582001036), from lots 6486 (Exp. 11/23), 6536 (Exp. 1/24), 6549 (Exp. 2/24), 6561 (Exp. 3/24), 6623 (Exp. 6/24), 6630 (Exp. 6/24), 6646 (Exp. 7/24), 6675 (Exp. 9/24), 6686 (Exp. 9/24), 6695 (Exp. 10/24), 6738 (Exp. 11/24), 6767 (Exp. 1/25), 6787 (Exp. 3/25), 6799 (Exp. 4/25), 6832 (Exp. 5/25), 6844 (Exp. 5/25), 6857 (Exp. 6/25), and 6888 (Exp. 7/25).

The product was distributed by Dr Berne’s Whole Health Products, Tesuque, New Mexico, throughout the United States, as well as in the United Kingdom, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, the Netherlands, Ireland, South Korea, Belgium, Norway, Saudi Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, and Barbados.

Dr Berne’s Whole Health Products voluntarily initiated the recall August 26, 2023. On October 4, 2023, the FDA designated the recall Class II, communicating that use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

“Using contaminated eye drops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection,” Dr Berne’s Whole Health Products stated in an August 26, 2023, company announcement. “To date, Dr Berne’s has received two reports of adverse events related to this recall.”

Dr Berne’s MSM Drops 15% Solution is used as a lubricating eye drop.