The U.S. Food and Drug Administration (FDA) has issued a warning regarding the sale of counterfeit eye drops in retail outlets primarily serving Spanish-speaking customers in Florida and Georgia.
The agency highlighted that some of these products are contaminated with bacteria that could lead to severe eye infections and potentially damage vision.
In the advisory released this Wednesday, the FDA identified five counterfeit over-the-counter eye drop products. According to official FDA information, these products might also be found in Louisiana, Mississippi, North Carolina, and other states, although the extent of their distribution is still under investigation.
The FDA did not disclose the names of the stores or cities where these counterfeits were found. While no adverse events have been reported so far, the agency advises against using these products due to unknown quality. Tests have confirmed bacterial contamination in two of them.
The contaminated products include Colirio Ocusan Rapid Redness Relief and Ocusan Dry Eyes, both identified as counterfeit versions of eye medications marketed by DLC Laboratories.
Tests conducted by DLC Laboratory revealed the presence of Staphylococcus bacteria in the first product, while the second one contained unidentified bacterial species.
The FDA cautioned that these contaminations could result in serious infections, potentially causing partial vision loss or blindness.
How to Spot the Counterfeits
A major clue for identifying these fakes is the batch number 5542D12, with an expiration date of December 2030. Despite sharing these details, the bottles have caps in different colors.
The counterfeit Colirio Ocusan Rapid Redness Relief features a red cap and packaging with information solely in Spanish. The box lacks the Drug Facts panel and has no printed information on the bottom.
Conversely, the authentic product, known as Colirio Ocusan Fast Redness Relief, comes with a white cap, English labeling, NDC code 24286-1575-1, and an expiration date of September 2027 or earlier. Its packaging includes a barcode and the label "Made in Korea."
The fake Ocusan Dry Eyes has a blue cap, batch number 5542D12, and an expiration of December 2030. It also features information only in Spanish, lacks the Drug Facts panel, and displays no data on the box's base.
The genuine version, Ocusan Dry Eyes, uses a white cap, bears the NDC code 24286-1292-5, and has an expiration of September 2027 or earlier. Both the bottle and box contain English information.
Additional Counterfeit Variants
The FDA also highlighted three other counterfeit variants. One is Colirio Manzanilla, mimicking the authentic Colirio Manzanilla A+ Redness Reliever & Lubricant.
The fake carries an expiration of December 2030 and displays the word "Alivia" in red, whereas the authentic product shows it in yellow. It lacks the word "STERILE" on the bottom left front of the box, the Drug Facts panel, and base information.
Another identified counterfeit is Manzanilla Sophia Úsala Diario, with an expiration of December 2030 and batch 160701DHR0. The fake packaging references a "Dina natural distributor" and suggests a maximum retail price of $33.
The fifth counterfeit is Manzanilla Sophia Ojo Rojo, sold in a red box featuring a red-eye image and an expiration of October 2030. The FDA noted that no authentic version of this product exists.
No confirmed bacterial contamination has been reported in these other three variants. However, their use is discouraged due to unknown quality and safety.
For consumers who have purchased any of the identified products, the official recommendation is to immediately cease their use.
If symptoms such as redness, discharge, eye pain, or discomfort occur after using the drops, individuals should consult a healthcare professional or seek medical attention promptly.
The FDA also advises against purchasing these items if they remain available in stores and recommends notifying the retailer of their presence.
Adverse effects can be reported through MedWatch, the FDA's official drug safety reporting system, or by calling 1-800-FDA-1088 (1-800-332-1088).
Eye Drop Safety Concerns in the U.S.
The issue of eye drop safety has prompted other recent health measures in the United States, albeit for different reasons.
In April 2026, 3,111,072 bottles of eye drops were recalled from chains like CVS, Walgreens, Publix, and other stores due to concerns about sterility assurance during manufacturing.
This recall by KC Pharmaceuticals did not mean all bottles were contaminated, but the company could not guarantee that their manufacturing process had prevented potential microbial contamination.
Understanding the FDA's Eye Drop Advisory
What prompted the FDA to issue this warning?
The FDA issued the warning after discovering counterfeit eye drops in stores serving Hispanic communities, some of which were contaminated with potentially harmful bacteria.
How can consumers identify counterfeit eye drops?
Consumers can identify counterfeit products by checking for batch number 5542D12 and an expiration date of December 2030, along with packaging details like cap color and language used.
What should consumers do if they have used these counterfeit products?
If symptoms such as redness, discharge, or eye pain occur, consumers should seek medical attention immediately. They should also stop using the product and report any adverse effects to the FDA's MedWatch system.