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Recalls & Safety AlertsVersion 6

FDA Lists Nationwide Recall of Rohto Cooling Eye Drops Max Strength Over Sterility Assurance

An FDA enforcement report records a Class II recall of more than six million cartons of the over-the-counter eye drops, initiated 14 July 2026 and still listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:16 a.m. ET
An FDA enforcement report, recall number , lists a nationwide U.S. recall of Rohto Cooling Eye Drops Max Strength for "." The recalling firm is listed as According to the record, the recall was initiated on 14 July 2026 and reported on 29 July 2026, and its status is listed as . The quantity is given as 6,076,306 cartons. The FDA record classifies the action as . Under the agency's own definitions, is the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The product is described in the enforcement record as Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), sterile, 0.4 fl oz (13 mL), distributed by The Mentholatum Company, Orchard Park, NY 14127, made in Vietnam, UPC 310742011012, NDC 10742-8158-1. The affected lots are listed as 3H2V and 3H3V (exp. 2026/07); 3J1V, 3J3V, 3J4V, 3J5V (exp. 2026/09); 3K1V, 3K2V (exp. 2026/10); 4A2V (exp. 2026/12); 4B1V, 4B2V, 4B3V (exp. 2027/01); "4F1V, 4F2V, 4F2V, 4F3V, 4F4V" as the record writes it, with lot 4F2V appearing twice (exp. 2027/05); 4G2V, 4G3V, 4G4V, 4G5V (exp. 2027/06); 4H1V (exp. 2027/07); and 4I1V, 4I2V, 4I4V, 4I5V (exp. 2027/08). By way of background, and separate from this recall, the U.S. National Library of Medicine's DailyMed drug labeling database and the FDA's National Drug Code Directory describe the product as a finished over-the-counter human drug: a sterile, water-based ophthalmic solution with labelled active ingredients naphazoline hydrochloride 0.03% and polysorbate 80 0.2%, packaged in a small squeeze bottle with a dropper applicator holding 13 mL (0.4 fl oz). The labelled directions are one or two drops in the affected eye or eyes up to four times daily, with the cap snapped back on after use and the product stored below 77°F. It is a retail product bought directly by shoppers off the shelf rather than a bulk ingredient, so those holding it are individual end users. Note that the enforcement record's product description reads "polysorbate 90" while the label database lists polysorbate 80. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action. The recall remains listed as .

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Revision history

  1. Version 67 Aug 2026, 13:16current

    Added source URLs for the FDA enforcement record, the agency's recall classification definitions and the product-labelling databases; no changes to the reported facts.

  2. Version 57 Aug 2026, 11:20

    Removed the inactive-ingredient list no longer supported by the reference data, added the labelled storage direction (below 77°F) and cited the FDA National Drug Code Directory alongside DailyMed.

  3. Version 47 Aug 2026, 05:44

    Added the full labelled inactive-ingredient list and packaging detail from DailyMed; removed the unsupported two-bottle carton listing reference.

  4. Version 37 Aug 2026, 01:44

    Added source links, quoted the lot list's duplicate 4F2V entry as written in the record, and flagged the polysorbate 90/80 discrepancy between the enforcement record and the label database.

  5. Version 26 Aug 2026, 21:52

    Background paragraph revised to match the sourced product description — removed the itemised inactive-ingredient list, added the dropper-bottle packaging, NDC code and the two-bottle carton variant, with source links added.

  6. Version 16 Aug 2026, 16:47

    First published.

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