Optometry AdvisorCounterfeit Eye Drops Found in Retail Locations of at Least 2 States, FDA Warns 

📋 Regulatory Action / Label Change

The FDA is investigating counterfeit over-the-counter eye drops identified in retail locations in Florida and Georgia and potentially distributed in Louisiana, Mississippi, and North Carolina. Testing cited in the alert identified bacterial contamination in certain counterfeit products, creating concern for potentially serious eye infections and vision complications. The FDA reported no known associated adverse events at the time of its warning.

Professional Impact

• Products implicated in the warning include counterfeit versions of Ocusan and Manzanilla-branded eye drops, along with a Manzanilla Sophia product for which the FDA says no authentic version exists.
• DLC Laboratories identified Staphylococcus bacteria in one tested product and an unconfirmed bacterial type in another.
• Packaging differences may help distinguish certain counterfeit products, but clinicians should obtain a detailed history of all ophthalmic products used when evaluating suspected infections.
• The FDA advises consumers to stop using the implicated products immediately.
• Patients developing redness, discharge, discomfort, or eye pain after using the products should contact a healthcare professional.
• The FDA investigation, testing, and efforts with distributors to remove unlawful products from the supply chain were ongoing.

Action Items

• Ask patients presenting with suspected ocular infection about all prescription and nonprescription eye products they use.
• Consider counterfeit-product exposure when symptoms follow use of potentially implicated OTC drops.
• Advise patients not to use products identified in the FDA warning.
• Report suspected adverse events involving these products through FDA MedWatch.
• Monitor FDA communications for updates as testing and the distribution investigation continue.