FDA Warns of Counterfeit Eye Drops Found in Two States
Fake over-the-counter drops have turned up in Florida and Georgia stores, and two tested samples carried bacteria.
The U.S. Food and Drug Administration has warned consumers not to use counterfeit over-the-counter eye drops found in Florida and Georgia. The products turned up in stores that mainly serve Spanish-speaking customers. Louisiana, Mississippi, North Carolina and possibly other states may also have them.
FDA says the quality of the fake products is unknown. Several tested positive for bacterial contamination, and they could cause injury, infection or vision problems.
What testing found
DLC Laboratory tested two of the counterfeits. Colirio Ocusan Alivio rapido del enrojecimiento contained Staphylococcus bacteria. Ocusan Ojos Secos was also contaminated, but the type of bacteria has not been confirmed. Such contamination may lead to serious eye infections, with partial vision loss or blindness as possible outcomes.
The agency says it knows of no adverse events tied to these products. Testing continues, and FDA is working with distributors to find and remove them.
How to tell them apart
Authentic Ocusan products carry a DLC Laboratories Inc. label, a white cap, English-only text, a Drug Facts panel and the words "Made in Korea." The counterfeit versions have Spanish-only text, no Drug Facts panel, a red or blue cap, lot 5542D12 and an expiration date of 12/2030.
FDA also lists fakes of chamomile-type drops sold as Colirio Manzanilla, which use a ProMex LLC label with no "STERILE" text, and two Laboratorios Sophia products. One of those, Manzanilla Sophia Ojo Rojo, has no authentic version at all.
People who used the products should stop and see a doctor if they have eye redness, discharge, pain or discomfort. Shoppers who see them on shelves should not buy them and should tell the store. Adverse events can be reported to FDA MedWatch online or at 1-800-FDA-1088. Clinicians are asked to check which eye products a patient with an infection has used.
Separately, K.C. Pharmaceuticals recalled one lot of Colirio Manzanill A+ Redness Reliever & Lubricant (lot AR25N01, expiring 11/2027) at retail level on Sept. 11, 2026.