The US Food and Drug Administration (FDA) announced that counterfeit versions of over-the-counter eye drops have been found in Florida and Georgia in stores serving primarily Spanish-speaking customers. These products also may be in Louisiana, Mississippi, North Carolina, and potentially other states, the FDA said.

“Do not use counterfeit eye drops as the quality is unknown and several of these products have tested positive for bacterial contamination. Using counterfeit eye drops can pose a serious risk to eye health and may cause injury, infection or vision problems,” the FDA said in the statement.

The FDA said it is not aware of adverse events associated with any of the counterfeit products. Its investigation and product testing are ongoing. The agency is working with distributors to identify, investigate, and remove unlawful eye drops found in the US drug supply.

The FDA provided product images and packaging details to help consumers and health care professionals distinguish counterfeit products from authentic versions.

According to the FDA, DLC Laboratory tested 2 counterfeit products and found bacterial contamination: 

• Colirio Ocusan Alivio rapido del enrojecimiento is contaminated with Staphylococcus bacteria

• Ocusan Ojos Secos is contaminated with an unconfirmed type of bacteria

This bacterial contamination may cause serious eye infections that could result in partial vision loss or blindness. Patients experiencing signs or symptoms of an eye infection after using any of these products should contact a health care professional or seek medical care immediately.

The FDA advised consumers to immediately stop using counterfeit eye drops and contact their physicians if they have concerns or experience signs of an eye infection, including redness, discharge, pain, or discomfort. The FDA also advised consumers who encounter these products on store shelves not to purchase them and to notify the retailer.

Consumers can report adverse events through FDA’s MedWatch reporting program either online or by phone: (800) FDA-1088 (800-332-1088). The FDA advised health care professionals to ask patients who have eye infections about all ophthalmic products they use and to report adverse events through its MedWatch reporting program.

One lot of Colirio Manzanill A+ Redness Reliever & Lubricant was recalled at the retail level on Sept. 11, 2026, by K.C. Pharmaceuticals. The recalled product is labeled with a lot number AR25N01 and expiration date of 11/2027.

Although PRO-MEX is listed as the distributor for both the recalled product and a counterfeit version identified by the FDA, the agency noted that the recall is separate from the counterfeit investigation. OM