One of the brand names on the FDA's new counterfeit eye drop list was already known to regulators. In November 2023, the FDA named Manzanilla Sophia Chamomile Herbal Eye Drops in a warning letter to Amazon and described it, along with six other eye products, as an unapproved new drug. That history matters now because fake Manzanilla Sophia drops, along with counterfeit Ocusan and Colirio Manzanilla products, are turning up in Florida and Georgia stores that mainly serve Spanish-speaking customers.
The FDA's alert on counterfeit eye drops found in several states says two of the fakes tested positive for bacteria, one of them Staphylococcus. The products may also be sold in Louisiana, Mississippi, North Carolina, and other states. For households that rely on familiar Spanish-labeled remedies, the concern now goes beyond spotting a fake box to asking whether a product was ever approved at all.