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Recalls & Safety AlertsVersion 6

FDA Records Nationwide Class II Recall of 499,673 Cartons of Rohto Cooling Eye Drops

An FDA enforcement report lists the reason as "Lack of Assurance of Sterility," with the recall status ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:44 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall in the United States of of Rohto Cooling Eye Drops Max Strength, a twin pack of 0.4 fl oz (13 mL) bottles. The record shows the recall was initiated on July 14, 2026, with a report date of July 29, 2026. The reason given is "." The recalling firm is listed as , with the product distributed by The Mentholatum Company of Orchard Park, New York. The status in the record is , and this remains a developing matter described here only as the record stands. The product is identified in the record by UPC 310742011210 and NDC 10742-8158-2, and by lot numbers 3H1V (Exp. 2026/07), 3J2V (2026/09), 4A1V and 4A1VA (2026/12), 4G1V (2027/06), 4I3V (2027/08), 5A1V (2027/12), 5B3V (2028/01), 5G3V (2028/06), 5J1V (2028/09), 5L1V (2028/11), 6A1V (2028/12), 6B4V (2029/01) and 6C2V (2029/02). The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The product is an over-the-counter ophthalmic liquid — a sterile, water-based solution in a small squeeze bottle with a dropper applicator, with naphazoline hydrochloride 0.03% and polysorbate 80 0.2% listed as active ingredients, according to drug labels filed with the U.S. National Library of Medicine's DailyMed. Those labels list inactive components including alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water and sodium borate; they direct one or two drops in the affected eye or eyes up to four times daily and mark the product for external use only. It is a finished consumer retail product sold without a prescription, so anyone holding it would be an ordinary household purchaser rather than a downstream manufacturer. The packaging states the product was made in Vietnam for distribution in the United States. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 13:44current

    Added the inactive-ingredient list from the DailyMed label filing; no change to the recall facts.

  2. Version 57 Aug 2026, 09:54

    Added the label's "external use only" marking and dropper-applicator detail from DailyMed; trimmed unsourced retail-channel description.

  3. Version 47 Aug 2026, 05:19

    Removed inactive-ingredient and package-registration details not present in the current reference set, and added the source URLs for the FDA record, the Class II definition and the DailyMed labels.

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