Counterfeit Versions of Eye Drops Found in Several States

Authentic vs. Counterfeit Products

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.

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 takes reports of counterfeit products seriously. The FDA is not aware of adverse events associated with any of these counterfeit products. The FDA’s investigation and product testing are ongoing. The agency is currently working with the distributors to identify, investigate and remove unlawful eye drops found in the U.S. drug supply.

Counterfeit eye drops with confirmed contamination

DLC Laboratory tested two 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 healthcare professional or seek medical care immediately.

Information for consumers

Immediately stop using these products. 
Contact your doctor if you have used any of these products and have concerns or signs of an eye infection, including eye redness, eye discharge and eye pain or discomfort. 
If you see these products on store shelves, do not purchase them and notify the store.   
Report adverse events through FDA’s MedWatch reporting program either online or by phone: 1-800-FDA-1088 (1-800-332-1088).  
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. While PRO-MEX is listed as the product distributor, which is the same as the product in the table, this recall is a separate issue from the counterfeit issue.

Information for health care professionals

If a patient has an eye infection, inquire about all ophthalmic products they use.   
Report adverse events through FDA’s MedWatch reporting program.

Information for retailers

Contact the company name on the product label if you suspect you have counterfeit products on your shelves.

How to identify the counterfeit products

Authentic product	Counterfeit product
Product: Colirio Ocusan Fast Redness Relief  Company on the label is DLC Laboratories Inc.  Carton is labeled with an expiration date of 9/2027 or earlier  Carton is labeled with NDC 24286-1575-1  Bottle has a white cap  Carton and bottle contain information in English only   Carton contains a Drug Facts panel  Bottom of the carton contains a barcode and ‘Made in Korea’	Product: Colirio Ocusan Alivio rapido del enrojecimiento  Company on the label is DLC Laboratories Inc.  Carton is labeled with an expiration date of 12/2030  Carton is labeled with lot number 5542D12  Bottle has a red cap   Carton and bottle contain information in Spanish only   Carton does not include a Drug Facts panel  Bottom of the carton does not contain any information
Product: Ocusan Dry Eyes  Company on the label is DLC Laboratories Inc.  Carton is labeled with an expiration date of 9/2027 or earlier  Carton is labeled with NDC 24286-1292-5  Bottle has a white cap  Carton and bottle contain only English language information  Carton contains a Drug Facts panel  The bottom of the carton contains a barcode and ‘Made in Korea’	Product: Ocusan Ojos Secos  Company on the label is DLC Laboratories Inc.  Carton is labeled with an expiration date of 12/2030  Carton is labeled with lot number 5542D12   Bottle has a blue cap   Carton and bottle contain only Spanish language information  Carton does not include a Drug Facts panel  Bottom of the carton does not contain any information
Product name: Colirio Manzanill A+ Redness Reliever & Lubricant  Company on the label is ProMex LLC; the side panel of the carton states the product is ‘Distributed By PRO-MEX'  Carton is labeled with an expiration date of 11/2027   The front of the carton contains the word ‘STERILE’ on the bottom left, and the word ‘Alivia’ is in yellow font  Back and side panels of the carton contain Drug Facts panels  Bottom of the carton contains lot number and expiration date	Product name Colirio Manzanilla  Company on the label is ProMex LLC  Carton is labeled with an expiration date of 12/2030  The front of the carton does not contain the word ‘STERILE’ on the bottom left, and the word ‘Alivia’ is in red font   Carton does not include a Drug Facts panel  Bottom of the carton does not contain any information
Product name: Manzanilla Sophia Usala Diario  Company on the label is Laboratorios Sophia  Carton side panel contains bold heading that reads ‘INSTRUCTIVO’ and contains images of opening the bottle, instilling the eye drop and closing the bottle  The other side panel of the carton contains a green bar on the top with white text that reads ‘FÓRMULA’	Product name: Manzanilla Sophia Usala Diario   Company on the label is Laboratorios Sophia  Carton is labeled with an expiration date of 12/2030  Carton contains lot number 160701DHR0  Carton side panel that states ‘Precio Maximo Al Publico $33.00’ over a red burst   Carton side panel and product bottle that states ‘Dina distribuidor naturista’
There is no authentic version of Manzanilla Sophia Ojo Rojo	Product name: Manzanilla Sophia Ojo Rojo   Company on the label is Laboratorios Sophia  Carton contains an expiration date 10/2030  Carton is red and contains an image of a red eye