WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the lot number on the bottle or package before using the product. The U.S. Food and Drug Administration says specified lots of eight Rohto Cooling Eye Drops products were recalled because the company could not assure their sterility.
The recall covers 11,960,623 cartons containing 12,460,649 bottles, according to the FDA’s enforcement report. The products were sold over the counter nationwide, including in Washington, D.C. No D.C.-specific distribution or illness linked to the recall was identified in the available records.
What does “lack of assurance of sterility” mean?
The FDA says the products have a “lack of assurance of sterility.” That means the sterility of the eye drops could not be confirmed, creating a potential risk that microorganisms could be present. The available information does not identify a specific contaminant or say that contamination was confirmed.
The FDA classified the recall as Class II. The agency uses that category when a product may cause temporary or medically reversible health effects, while the probability of serious adverse health consequences is considered remote.
Which products are included?
The recall involves eight Rohto Cooling Eye Drops product varieties, including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief. Some products were sold as single bottles and others in twin packs.
Only particular lots are affected. The FDA’s recall list identifies the affected lot numbers and expiration dates, which are printed on the packaging. Reports describing the FDA listing have differed on the earliest expiration date, so consumers should compare the full lot information with the agency’s current list rather than rely only on a product name or date range.
What should consumers do?
The FDA advises consumers with an affected product to stop using it. The agency says the product should be disposed of or returned to the place of purchase.
The recall was initiated voluntarily by Rohto-Mentholatum on July 14, 2026, and the FDA classified it on July 23, 2026. The products were manufactured in Vietnam and distributed by The Mentholatum Company, according to manufacturer and FDA information cited in the recall coverage.
The records available for this report do not identify a named FDA spokesperson, a specific contamination event or a confirmed illness connected to the products. Consumers with health concerns related to eye-drop use should contact a health professional, rather than continue using a recalled product.
