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# FDA Warns 8 Firms for Unapproved Eye Drugs
- URL: https://www.fdaweb.com/fda-warns-8-firms-for-unapproved-eye-drugs/
- Published: 2023-09-12T12:00:00.000Z
- Updated: 2026-09-14T18:55:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155304

FDA has issued Warning Letters to eight companies for illegally manufacturing or marketing unapproved ophthalmic products. An agency online [notice](https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products?utm%5Fmedium=email&utm%5Fsource=govdelivery) (includes links to the eight Warning Letters) says the companies’ unapproved drugs are marketed to treat conjunctivitis, cataracts, glaucoma, and other ophthalmic conditions. Some of the letters also identify CGMP issues at the companies, the agency says.

“FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the notice says…. “Additionally, unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.”

The letters were issued to:

- Boiron
- CVS Health
- DR Vitamin Solutions
- Natural Ophthalmics
- OcluMed LLC
- Similasan AG/Similasan USA
- TRP Company
- Walgreens Boots Alliance, Inc.

The agency says that consumers using products included in the Warning Letters for any of the companies should talk with their healthcare professionals.

The letters tell the companies to respond with lists of specific actions they are taking to correct the violations. FDA says it could pursue legal action if any of the companies fail to correct the violations promptly.