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Recalls & Safety AlertsVersion 6

FDA Records Class II Nationwide Recall of 1.28 Million Cartons of Rohto Optic Glow Eye Drops

An FDA enforcement report cites "Lack of Assurance of Sterility" for the over-the-counter eye drops, with the recall listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:16 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall in the United States of Rohto Cooling Eye Drops Optic Glow, covering . The record names the recalling firm as , gives the reason as "," and lists the recall status as . The action was initiated on July 14, 2026 and reported on July 29, 2026. This is a developing matter and the agency's record may change. The FDA classified the recall as . Under the agency's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The enforcement report describes the product as Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), sterile, 0.4 FL OZ (13 mL), distributed by The Mentholatum Company, Orchard Park, NY 14127, made in Vietnam, UPC 310742010916, NDC 10742-8160-1. Background product records published by DailyMed describe it as a sterile, water-based ophthalmic solution — drops applied directly into the eye — registered as a human over-the-counter drug, produced in Vietnam and sold ready to use in a 13 mL (0.4 fl oz) squeeze-dropper bottle in a carton, bought off the shelf without a prescription. The people holding it are ordinary shoppers rather than manufacturers or trade buyers. That description is background only and says nothing about this recall. The listed lot numbers and expiration dates are: 3H1V and 3H1VA (Exp. 2025/07); 3J1V and 3J2V (Exp. 2025/09); 3K1V (Exp. 2025/10); 4F1V (Exp. 2027/05); 4F1VA and 4H1V (Exp. 2027/07); 4I1V (Exp. 2027/08); 4K1V and 4K2V (Exp. 2027/10); 5A1V and 5A2V (Exp. 2027/12); 5D1V (Exp. 2028/03); 5E1V (Exp. 2028/04); 5J1V and 5J2V (Exp. 2028/09); 6B1V (Exp. 2029/01); and 6C1V, 6C1VA and 6C1VB (Exp. 2029/02). The record lists lot 4F1VA between the two expiration dates, so which date it belongs to is unclear from the entry as written. The FDA's enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:16current

    No new facts in the record; headline and dek added, story text unchanged.

  2. Version 57 Aug 2026, 11:44

    Trimmed the product-background paragraph to the composition, route and packaging supported by the DailyMed records, removing the inactive-ingredient list and dosing directions.

  3. Version 47 Aug 2026, 05:07

    Added DailyMed/NDC product background (inactive ingredients, packaging, directions, OTC retail sale) and flagged that the record's placement of lot 4F1VA between two expiration dates is unclear.

  4. Version 37 Aug 2026, 02:33

    Removed the unsourced DailyMed product description and packaging/retail detail, reduced the product background to the supported dosage-form line, and wrote the initiation and report dates out in full.

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