FDA Flags Counterfeit Eye Drops in Several States

Counterfeit eye drops are back on FDA's radar — this time as fakes of two Spanish-labeled, over-the-counter brands sold in stores serving Spanish-speaking shoppers in Florida and Georgia. On 16 October 2026, FDA posted a consumer notice identifying the counterfeits, disclosing that one tested positive for bacterial contamination, and warning that the same packaging could have reached other states.

What FDA found, and where

FDA's Counterfeit Medicine program tracks fraudulent drug products reaching the U.S. market outside the legitimate supply chain, and the 16 October notice is the latest entry. The agency identified counterfeit versions of two over-the-counter eye-care lines carrying Spanish-language labeling: Colirio Ocusan products labeled as made by DLC Laboratories Inc., including a redness reliever marketed as “Alivio rápido del enrojecimiento” and a dry-eye product sold as Ocusan Dry Eyes, and a Manzanilla-branded redness reliever and lubricant labeled under ProMex LLC. FDA says the fakes turned up predominantly in stores that mainly serve Spanish-speaking customers in Florida and Georgia, and that identical or similar counterfeit packaging could plausibly have reached other states it has not yet confirmed.

A contaminated sample, and an open investigation

The detail that moves this from a labeling problem to a safety hazard: DLC Laboratories tested a counterfeit sample of its own Colirio Ocusan redness-relief product and found it contaminated with Staphylococcus bacteria — a pathogen capable of causing serious eye infections, including corneal ulcers, in a product applied directly to the eye. FDA says it is not aware of any adverse events connected to these specific counterfeit products to date, but cautions that its investigation and product testing are ongoing, which leaves open the possibility that additional contaminated lots or additional affected brands surface as the inquiry continues.

Why this keeps happening to eye drops

This is not FDA's first eye-drop contamination warning in recent years, and the agency's own counterfeit-medicine page frames eye drops as a recurring target: they are cheap, widely stocked in independent and ethnic-market retail outlets with thinner supply-chain oversight than national chains, and consumers have little way to verify sterility by looking at a sealed bottle. A counterfeiter who matches the carton design closely enough can get a fake onto a shelf next to the real product with minimal scrutiny — and because eye drops are applied directly to a mucous membrane, a sterility failure that would be a minor quality defect in an oral product becomes an infection risk.

What this means for pharmacists and distributors

• Check NDC numbers against the labeling on hand — FDA's notice lists the specific National Drug Code numbers that appear on genuine cartons for each affected product, which counterfeits have altered or omitted.
• Inspect for a Drug Facts panel — several of the counterfeit cartons FDA describes are missing the Drug Facts panel required on legitimate OTC drug packaging.
• Scrutinize expiration dates and lot coding — FDA's side-by-side comparisons show counterfeit cartons using inconsistent date formats or implausible expiration windows next to the authentic product.
• Pull any suspect stock and report it — FDA asks pharmacists, distributors, and consumers who encounter suspected counterfeit units to report them through MedWatch and to avoid using or dispensing the product pending confirmation.

Frequently asked questions

What did FDA announce on 16 October 2026?

FDA identified counterfeit versions of two Spanish-labeled over-the-counter eye drop brands — products carrying the labeling of DLC Laboratories Inc. (Colirio Ocusan) and ProMex LLC (Manzanilla-branded redness reliever) — found predominantly in retail stores serving Spanish-speaking communities in Florida and Georgia.

Were any of the counterfeit products contaminated?

Yes. DLC Laboratories tested samples of the counterfeit Colirio Ocusan redness-relief product and found it contaminated with Staphylococcus bacteria. FDA says its own investigation and product testing are continuing.

Have any injuries been reported?

FDA says it is not aware of any adverse events tied to these specific counterfeit products so far, but it is still investigating and advises consumers and pharmacists not to use or sell the affected lots.

How can a pharmacist or consumer tell a counterfeit from the real product?

FDA's notice walks through label-by-label differences for each counterfeit it has identified: mismatched or missing NDC numbers, altered expiration dates, and cartons missing the required Drug Facts panel that appears on the authentic product.