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# Dr. Berne’s Selling Unapproved, Adulterated Eye Drops
- URL: https://www.fdaweb.com/dr-bernes-selling-unapproved-adulterated-eye-drops/
- Published: 2023-11-28T12:00:00.000Z
- Updated: 2026-09-14T14:17:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155868

FDA says its review of a Web site maintained by Dr. Berne’s Whole Health Products in Tesuque, NM, determined that the site offers three illegal eye drop products for sale in the U.S. An 11/22 Warning Letter says the products are unapproved new drugs and are adulterated. The letter says the eye drops are especially concerning from a public health perspective because ophthalmic drug products intended for administration into the eye generally pose a greater risk of harm to users since their route of administration bypasses some of the body’s natural defenses.

The letter says the three eye drop products are not generally recognized as safe and effective for their intended uses and thus are legally considered to be new drugs for which the company does not have an approved application.

According to FDA, laboratory testing of one of the products found that it contained microbial contamination. It says fungal and bacterial microorganisms were identified from drug product samples analyzed for sterility.

The agency says the company indicated its products are manufactured by a contract facility and it agreed to a voluntary recall. FDA reminded Dr. Berne’s that it is responsible for the quality of its drugs regardless of agreements in place with contract facilities.

Dr. Berne’s was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.