FDA Flags Counterfeit Eye Drops in Multiple States After Bacterial Contamination Was Found
Counterfeit over-the-counter eye drops have surfaced in Florida and Georgia, with possible distribution in Louisiana, Mississippi, North Carolina, and other states. The products are appearing in stores that primarily serve Spanish-speaking customers, a detail that raises concern about how easily unsafe ophthalmic products can move through retail channels when labeling and language match a target market closely enough to look legitimate at a glance.
The stakes are high because these are not cosmetic defects or simple labeling errors. Several of the counterfeit products tested positive for bacterial contamination, and contaminated eye drops can seed the ocular surface with organisms that should never be there. In practice, that means conjunctivitis can become keratitis, and a seemingly minor bout of redness can escalate into partial vision loss or blindness if infection reaches deeper ocular structures.
Contamination Turns a Routine Product Into a Direct Threat to the Eye
FDA investigators have identified counterfeit versions of multiple products, including Colirio Ocusan Fast Redness Relief, Ocusan Dry Eyes, Colirio Manzanill A+ Redness Reliever & Lubricant, Manzanilla Sophia Usala Diario, and Manzanilla Sophia Ojo Rojo. The counterfeit status of these products is established through packaging differences, language inconsistencies, missing Drug Facts panels, altered cap colors, altered expiration dates, and absent product information on carton bottoms.
Two products tested by DLC Laboratory were found to contain bacteria. Colirio Ocusan Alivio rapido del enrojecimiento was contaminated with Staphylococcus bacteria, and Ocusan Ojos Secos contained an unconfirmed type of bacteria. For an ophthalmic product, contamination is especially dangerous because the eye is not built to tolerate microbial exposure from repeated dosing. Each instillation bypasses the body’s usual external barriers and delivers any contaminant directly to a delicate, highly innervated surface.
The clinical implication is immediate. Eye pain, discharge, redness, or discomfort after using any of these products should be treated as a possible infection signal rather than a trivial irritation. Delayed evaluation can allow bacterial replication and corneal involvement before a patient recognizes how serious the exposure has become.
Packaging Clues Separate Legitimate Products From Counterfeits
The FDA’s identification guide relies on concrete visual differences. Authentic Colirio Ocusan Fast Redness Relief and Ocusan Dry Eyes are labeled with DLC Laboratories Inc., carry expiration dates of 9/2027 or earlier, display specific NDC numbers, use white caps, include English-only labeling, and contain a Drug Facts panel. Their cartons also list a barcode and the words “Made in Korea.” The counterfeit versions differ in several ways, including expiration dates of 12/2030, lot number 5542D12, colored caps, Spanish-only text, missing Drug Facts panels, and blank carton bottoms.
The same kind of inconsistency appears in the Manzanilla products. Authentic Colirio Manzanill A+ Redness Reliever & Lubricant carries a front-panel “STERILE” designation, yellow “Alivia” text, Drug Facts panels on the back and side, and lot and expiration information on the bottom. The counterfeit version lacks those features and shows a different expiration date and carton layout. For Manzanilla Sophia Usala Diario, one version carries instructional graphics and a green “FÓRMULA” bar, while another version lists an expiration date of 12/2030, lot number 160701DHR0, and promotional markings that do not match the authentic presentation.
The product Manzanilla Sophia Ojo Rojo presents a different problem: there is no authentic version of it. Any version offered for sale should be treated with heightened suspicion.
What Patients Should Do After Using These Products
Consumers who have used any of the listed counterfeit eye drops should stop immediately. If eye redness, discharge, pain, or discomfort appears after use, a healthcare professional should be contacted without delay. When symptoms follow exposure to a contaminated ophthalmic product, the differential diagnosis should include bacterial infection until proven otherwise, not simple irritation from a preserved or drying formulation.
The FDA is not aware of adverse events linked to these counterfeit products at this time, but the investigation and product testing are still ongoing. The agency is working with distributors to identify, investigate, and remove unlawful eye drops from the U.S. drug supply. Even without confirmed injury reports, the microbiology alone is enough to justify urgent public health action.
Patients should also avoid purchasing these products if they appear on store shelves and notify the retailer. Adverse events can be reported through FDA’s MedWatch program online or by phone at 1-800-FDA-1088.
Why Clinicians Should Ask About All Ophthalmic Products
For health care professionals, the most useful move is a broad medication history that includes every eye product a patient has used, not just prescription drops. Counterfeit ophthalmic products may be missed if the clinician assumes the patient is using a standard, well-characterized preparation. In a patient with conjunctival injection, discharge, corneal symptoms, or pain, the history should quickly move beyond symptom control and into product sourcing, packaging, language, cap color, and place of purchase.
If an eye infection is present, asking specifically about over-the-counter drops is essential because the exposure history may explain why a routine infection is unusually aggressive or refractory. Contaminated drops create a direct inoculation route, and repeated use can keep reintroducing bacteria even after initial treatment begins.
Retail Surveillance Remains Part of the Safety Net
Retailers are advised to contact the company name on the product label if counterfeit products are suspected on shelves. In parallel, the retail-level recall of one lot of Colirio Manzanill A+ Redness Reliever & Lubricant adds a separate issue that should not be confused with the counterfeit concern. That recalled lot is labeled AR25N01 with an expiration date of 11/2027 and was recalled on Sept. 11, 2026, by K.C. Pharmaceuticals.
The practical message is straightforward: visually similar eye drops can conceal very different safety profiles, and in this case, the packaging differences are not cosmetic. They are the signal that the supply chain has been compromised. For the eye, a contaminated counterfeit product is not merely unauthorized—it is a potential infectious inoculum delivered directly to a vulnerable organ.