The United States Food and Drug Administration (FDA) has issued a warning about the sale of counterfeit eye drops in retail establishments in Florida and Georgia that primarily serve Spanish-speaking customers.
The agency warned that some of the products contain bacteria capable of causing severe eye infections and compromising vision.
The warning, released this Wednesday, identifies five counterfeit versions of over-the-counter eye drops. According to the official information published by the FDA, the products may also be found in Louisiana, Mississippi, North Carolina, and other states, although investigations are still underway to determine the extent of their distribution.
The agency did not publicly identify the stores or cities where they were found, nor has it received reports of adverse events associated with these counterfeits. However, it recommends ceasing use of these products immediately because their quality is unknown, and two of them tested positive for bacterial contamination.
The products that have confirmed contamination are Ocusan Eye Drops Rapid Relief from Redness and Ocusan Dry Eyes, both identified as counterfeit versions of ophthalmic medications marketed by DLC Laboratories.
In the tests conducted by DLC Laboratory, the first sample showed bacteria from the genus Staphylococcus, while the second sample contained bacteria of a type that has yet to be confirmed.
The FDA warned that these contaminants can cause serious infections that may lead to partial vision loss or blindness.
One of the main indicators to identify both counterfeits is the lot number 5542D12, accompanied by an expiration date of December 2030. Although they share that information, the bottles have different colored caps.
The false Colirio Ocusan Quick Relief from Redness features a red cap and its packaging contains information exclusively in Spanish. Additionally, the box lacks the pharmacological information panel referred to as Drug Facts and has no printed information on the bottom.
On the contrary, the authentic product identified by the FDA, named Colirio Ocusan Fast Redness Relief, has a white cap, information in English, NDC code 24286-1575-1, and an expiration date of September 2027 or earlier. Its box includes a barcode and the indication "Made in Korea".
In the case of the fake Ocusan Ojos Secos, the bottle has a blue cap, lot number 5542D12, and expiration date 12/2030. It also only contains information in Spanish, lacks the Drug Facts panel, and does not display any data on the bottom of the box.
Its authentic version, Ocusan Dry Eyes, uses a white cap, bears the NDC code 24286-1292-5, and has an expiration date of September 2027 or earlier. Both the bottle and the box contain information in English.
The FDA published a comparative chart of authentic and counterfeit products, featuring photographs of the packaging, labels, and bottles, to aid in their identification.
The alert includes three other counterfeit products. One of them is Colirio Manzanilla, which imitates the authentic medication Colirio Manzanill A+ Redness Reliever & Lubricant.
The counterfeit product has an expiration date of 12/2030 and features the word "Alivia" in red, while the authentic product displays it in yellow. It also lacks the word "STERILE" in the lower left corner on the front of the box, on the Drug Facts panel, and in the information at the base of the container.
Another identified product is Manzanilla Sophia Úsala Diario, with an expiration date of 12/2030 and lot number 160701DHR0. The FDA indicates that the counterfeit packaging includes a reference to "Dina naturist distributor" and a maximum retail price of 33 dollars.
The fifth counterfeit corresponds to Manzanilla Sophia Ojo Rojo, marketed in a red box featuring an image of a red eye and an expiration date of 10/2030. Regarding this presentation, the FDA made an important clarification: there is no authentic version of this product.
The authorities did not report confirmed bacterial contamination in these other three presentations. However, they also advise against their use due to the unknown quality and safety.
For those who have purchased any of the identified products, the official recommendation is to immediately suspend their use.
If redness, discharge, pain, or discomfort in the eyes occurs after applying the drops, the person should consult a healthcare professional or seek medical attention without delay.
The FDA also recommends not purchasing these items if they are still in stores and informing the establishment about their presence.
Possible adverse effects can be reported through MedWatch, the official medication safety reporting system, or by calling 1-800-FDA-1088 (1-800-332-1088).
The issue of the safety of eye drops 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 that were sold in chains such as CVS, Walgreens, Publix, and other stores, due to issues related to sterility guarantees during their manufacturing.
That recall, made by KC Pharmaceuticals, did not imply that all the vials were contaminated. The company could not guarantee that its manufacturing process had prevented potential microbial contaminations.
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