WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the lot number and expiration date on the package before using the product. The U.S. Food and Drug Administration says certain lots of eight Rohto Cooling Eye Drops products were recalled because the manufacturer could not assure that they were sterile.
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 and distributed nationwide, including in Washington, D.C.
What does “lack of assurance of sterility” mean?
The FDA’s stated reason for the recall is a “lack of assurance of sterility.” That means the products’ sterility could not be confirmed, creating a potential risk that microorganisms could be present. The FDA information does not identify a specific contaminant or say that contamination was confirmed.
The recall was classified as Class II. The FDA defines a Class II recall as one involving products that may cause temporary or medically reversible health effects. The agency says the probability of serious adverse health consequences is remote.
Which products are affected?
The recall involves eight Rohto Cooling Eye Drops varieties and single- or twin-pack configurations. Products identified in the recall information include All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief.
The product name alone is not enough to determine whether a bottle is recalled. The FDA says only specified lot numbers are affected. Lot numbers and expiration dates are printed on the product packaging and should be compared with the FDA’s official recall list.
The expiration dates reported for affected products extend into 2029. Because product lists and date ranges published in reports have differed, consumers should rely on the lot-by-lot information in the FDA recall listing rather than a general date range.
What should consumers do?
The FDA advises consumers to stop using an affected product. It may be disposed of or returned to the place of purchase.
Rohto-Mentholatum reportedly began the voluntary recall July 14, 2026. The FDA classified it as Class II on July 23, 2026. The products were manufactured in Vietnam and distributed by The Mentholatum Company, according to manufacturer and distributor recall information.
The recall information available for this report does not identify a confirmed illness linked to the products. Consumers who have questions about a specific bottle should compare its lot number and expiration date with the FDA’s recall list before using it.
