Federal regulators are overseeing a nationwide recall of almost 12 million cartons of eye drops because the products may not meet sterility standards.
Included in this recall are several over-the-counter products promoted for eye redness, dryness, and strain.
What happened?
Citing a Food and Drug Administration enforcement report, Fox Business reported that Rohto-Mentholatum, a manufacturer based in Vietnam, initiated the voluntary recall of Rohto Cooling Eye Drops sold across the country.
The agency said the action stemmed from a "lack of assurance of sterility," indicating the drops could not be verified as being free of potentially dangerous microorganisms.
The Food and Drug Administration placed the matter in its Class II category of recalls, which is used when a product could cause temporary or medically reversible health problems but when serious consequences are not expected, per Fox Business.
The affected products include eight Rohto Cooling Eye Drops items sold in single- and twin-pack versions, including All-in-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief. Their expiration dates range from July 2025 through February 2029.
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The recall's event ID is 99440.
Why does it matter?
Eye drops are applied directly to a highly sensitive part of the body, which is why sterility is especially important.
If an ophthalmic product is contaminated, even a relatively low-probability problem can become serious for people with eye injuries, compromised immune systems, or underlying eye conditions or those who have undergone recent surgeries.
In this case, the classification suggests the threat is not expected to be harmful for most people, but it is still serious enough that consumers were told to stop using the products.
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The recall also comes amid a string of recent medication and eye care product recalls, including millions of bottles of a prescription steroid eye medicine and certain generic allergy tablets that were flagged over separate safety concerns.
Consumers who have Rohto eye drops can use the lot number and expiration date on the box or bottle to check the recall notice or FDA website to determine whether their product was included.
If the product is in the recall, the FDA says people should stop using it immediately. Customers can throw the eye drops away or return them to the place of purchase for a refund.
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