Nearly 12 million bottles of Rohto eye drops are being recalled nationwide because their sterility cannot be assured.
The recall covers several Rohto Cooling Eye Drops products made in Vietnam between July 2023 and March 2026.
Consumers should stop using recalled drops and check the lot number and expiration date against the recall list.
Consumers are being urged to check their medicine cabinets after nearly 12 million bottles of Rohto eye drops were recalled because of concerns that the products may not be sterile.
The nationwide recall was initiated by Rohto-Mentholatum (Vietnam) Co. Ltd. The products were distributed in the United States by The Mentholatum Company of Orchard Park, New York. The Food and Drug Administration (FDA) classified the action as a Class II recall. That classification means exposure to a recalled product could cause temporary or medically reversible health problems, but the likelihood of serious consequences is considered low.
The FDA cited a “lack of assurance of sterility” as the reason for the recall. The agency’s notice does not necessarily mean contamination was found in every bottle. It means the manufacturer cannot adequately guarantee that the affected products are free from microorganisms.
That distinction is important because eye drops bypass some of the body’s natural defenses. Contaminated drops can potentially cause eye infections, with greater risks for people who have weakened immune systems, eye injuries, or recent eye surgery.
Which products are included?
The recall covers affected lots of several over-the-counter products, including:
Rohto Cool Relief, 13 mL
Rohto All-in-One, 13 mL
Rohto Max Strength, 13 mL
Rohto Optic Glow, 13 mL
Rohto Digi-Eye, 13 mL
Rohto Dry Aid, 10 mL
Some products were sold as individual bottles and others in two-bottle packages. Altogether, published reports based on FDA enforcement records place the number of affected bottles at approximately 12 million.
The recalled lots were manufactured in Vietnam between July 2023 and March 2026. Expiration dates range from July 2025 through February 2029, meaning consumers could still have the drops at home even if they were purchased months or years ago.
Because the recall contains more than 180 combinations of products, lot numbers, and expiration dates, consumers should not rely on the product name alone. The lot code and expiration date printed on the bottle or carton should be compared with the complete recall list.
What consumers should do
Anyone who has an affected product should stop using it. The drops can be discarded safely or returned to the retailer, depending on the seller’s recall and refund policy.
Consumers who develop eye pain, swelling, discharge, unusual redness, blurred vision, light sensitivity, or other changes after using the drops should contact a healthcare professional promptly. Serious or unexpected reactions can also be reported through the FDA’s MedWatch program.
Consumers should never touch the tip of an eye-drop bottle to the eye, eyelid, fingers, or another surface, since doing so can introduce bacteria into the container. Bottles should not be shared with other people.
The recall applies only to the specified Rohto products and lots manufactured in Vietnam. Other Rohto products are not automatically included, but consumers should check the identifying information carefully before continuing to use any bottle covered by the notice.