FDA Flags Bacterial Contamination Risk in Counterfeit DLC Laboratories and ProMex Eye Drops Across Six States

Bacterial contamination confirmed in counterfeit OTC eye drops circulating across at least six states is forcing QA directors and supply chain managers to reassess distributor vetting and retail authentication protocols. FDA has identified counterfeit versions of products bearing the labels of DLC Laboratories Inc., ProMex LLC, and Laboratorios Sophia in Florida and Georgia, with potential distribution extending into Louisiana, Mississippi, and North Carolina.

The affected SKUs span four product lines: Colirio Ocusan Fast Redness Relief, Ocusan Dry Eyes, Colirio Manzanilla A+ Redness Reliever & Lubricant, and Manzanilla Sophia Usala Diario. A fifth product, Manzanilla Sophia Ojo Rojo, has no authentic counterpart, meaning any unit encountered in the supply chain is, by definition, counterfeit. Products were found predominantly in stores serving Spanish-speaking communities, a channel that may receive less routine compliance scrutiny.

Authentication differentiators are specific and actionable. Counterfeit DLC Laboratories units carry a uniform expiration date of 12/2030 and lot number 5542D12, lack a Drug Facts panel, and bear no barcode or country-of-origin marking on the carton base. Authentic DLC units show expiration dates of 9/2027 or earlier, NDC numbers, English-only labeling, and a "Made in Korea" barcode. For the ProMex line, the absence of the word "STERILE" on the carton front and red, rather than yellow, font for "Alivia" are the primary visual indicators of a counterfeit unit.

From a 21 CFR Part 211 and supply chain integrity standpoint, the absence of Drug Facts panels and lot traceability on counterfeit units represents a failure point that legitimate distributors should be able to detect at intake. FDA states it is working with distributors to identify, investigate, and remove unlawful product from the U.S. drug supply; no adverse events have been reported to the agency as of the alert date, though product testing remains ongoing.

For QA leads, the more durable concern is channel visibility: counterfeit infiltration concentrated in regional, community-facing retail suggests that secondary and tertiary distributors may not be applying the same authentication rigor as primary wholesalers. Reviewing distributor qualification records and incoming goods inspection SOPs against the specific label and lot indicators FDA has published is the near-term operational priority.

FDA's ongoing testing means additional SKUs or geographies could be added to the alert, making this a live compliance checkpoint rather than a closed incident.

Source: FDA via What's New: Drugs RSS Feed, 16 October 2026.