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Recalls & Safety AlertsVersion 6

FDA Lists Class II Recall of 2.9 Million Cartons of Rohto Cooling Eye Drops

An FDA enforcement report records Rohto-Mentholatum (Vietnam) Co., Ltd. recalling 2,910,148 cartons of Rohto Cooling Eye Drops Cool Relief for "Lack of Assurance of Sterility," with the action listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:42 a.m. ET
has recalled 2,910,148 cartons of Rohto Cooling Eye Drops Cool Relief because of a "," according to an FDA enforcement report carrying recall number . The report lists the recall as initiated on 14 July 2026, with a report date of 29 July 2026, and the status as . Distribution is listed as . The product is described in the record as naphazoline hydrochloride 0.012% and polysorbate 80 0.2%, sterile, 0.4 fl oz (13 mL) each, distributed by The Mentholatum Company of Orchard Park, NY 14127, made in Vietnam, UPC 310742010749, NDC 10742-8141-1. The affected lots listed are 3J1V (exp. 2026/09); 4A1V (2026/12); 4G1V and 4G2V (2027/06); 4I1V (2027/08); 4JIV (2027/09); 5A1V (2027/12); 5B1V (2028/01); 5F1V and 5F1VA (2028/05); 5H1V and 5H1VA (2028/07); 5J1V and 5J1VA (2028/09); 5L1V (2028/11); and 6B1V (2029/01). The FDA classified the action as , with a classification date of 29 July 2026 in the enforcement record. The agency defines as its middle category, used where a product may cause temporary or medically reversible harm and where the probability of serious harm is remote. According to the FDA drug listing published in the U.S. National Library of Medicine's DailyMed database, the item is a sterile, water-based over-the-counter liquid in a 13 mL dropper bottle, applied by instilling one or two drops into the eye up to four times a day. Besides the two stated active constituents — naphazoline hydrochloride, a synthetic imidazoline compound (C14H15ClN2), and polysorbate 80, a synthetic surfactant made from sorbitan fatty acid esters reacted with ethylene oxide — the listing records purified water, alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol and sodium borate. It is sold as a finished consumer product off the shelf without a prescription in pharmacies, supermarkets and general retailers, and is not supplied as a bulk ingredient, so those holding it are ordinary individual purchasers. 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 and the record is developing.

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Revision history

  1. Version 67 Aug 2026, 13:42current

    Added headline and dek, and described the two active ingredients from the reference chemical listings; recall facts unchanged.

  2. Version 57 Aug 2026, 11:18

    Added the 29 July 2026 classification date and the labelled dosing detail from the DailyMed listing; source URLs now cited.

  3. Version 47 Aug 2026, 05:46

    Product paragraph rewritten to match the DailyMed drug listing, adding the recorded inactive ingredients and removing a dosing frequency not supported by the reference record.

  4. Version 37 Aug 2026, 01:40

    Added the labelled dosing directions from DailyMed and gave the story a headline and dek; recall facts unchanged.

  5. Version 26 Aug 2026, 21:54

    Added headline and dek, and aligned the product description with the DailyMed label wording; facts unchanged.

  6. Version 16 Aug 2026, 16:44

    First published.

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