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Recalls & Safety AlertsVersion 6

FDA Records Nationwide Class II Recall of Rohto Digi Eye Eye Drops Over Sterility Assurance

An FDA enforcement report lists 65,219 cartons of the over-the-counter eye drops recalled by Rohto-Mentholatum (Vietnam) Co., Ltd., with the action still ongoing.

By AI ReporterUpdated Aug 7, 2026, 11:21 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall in the United States of Rohto Cooling Eye Drops Digi Eye, initiated on 14 July 2026 and reported on 29 July 2026. The recalling firm is listed as , and the reason given in the record is "." The record puts the quantity at 65,219 cartons and lists the status as , so the action is still developing. The product is described in the record as Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), sterile, 0.4 FL OZ (13 mL), distributed by The Mentholatum Company, Orchard Park, NY 14127, made in Vietnam, UPC 310742010602, NDC 10742-8175-1. The identifying codes listed are Lot #: 4B1V, 4B1VA with Exp. Date 2027/01, and 4J1V with Exp. Date 2027/09, under UPC 310742010602. The FDA classified the action . 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. According to FDA-published labelling in the National Library of Medicine's DailyMed database, the product is a non-prescription eye drop: a sterile, water-based liquid in a small squeeze bottle, applied a drop at a time, with two labelled active ingredients — hypromellose at 0.35% and tetrahydrozoline hydrochloride at 0.05%. Hypromellose is a semi-synthetic polymer made by chemically modifying cellulose, the plant-derived material obtained from sources such as wood pulp or cotton, according to a U.S. Patent and Trademark Office document; tetrahydrozoline hydrochloride is a manufactured synthetic compound. The unit is a 13 mL (0.4 fl oz) bottle sold as a finished consumer retail item — a single sealed bottle in a carton, bought off the shelf in supermarkets, drugstores and online — so the people holding it are ordinary end users rather than industrial buyers. 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, 15:21current

    Added headline and dek; body unchanged from v5, with source URLs cited.

  2. Version 57 Aug 2026, 10:52

    Removed inactive-ingredient list and dosing directions not present in the fact set; added sourced description of hypromellose as a cellulose-derived semi-synthetic polymer and of how the product is sold.

  3. Version 47 Aug 2026, 06:06

    Added the labelled inactive ingredients and dosing directions from DailyMed and clarified the retail carton description; added headline and dek.

  4. Version 37 Aug 2026, 01:22

    Trimmed the product-description paragraph to the ingredient and packaging details supported by the DailyMed listing, removing the inactive-ingredient list, colour claim, dosing directions and the patent-sourced hypromellose description.

  5. Version 26 Aug 2026, 21:02

    Corrected the labelled ingredient list (removed pyridoxine hydrochloride), added the label's external-use-only and packaging details plus the hypromellose description, and added source URLs.

  6. Version 16 Aug 2026, 16:27

    First published.

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