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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 97,201 Cartons of Rohto Cooling Eye Drops Dry Aid

The agency's enforcement report for recall D-0720-2026 gives the reason as "Lack of Assurance of Sterility" and lists the action as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:17 a.m. ET
The U.S. Food and Drug Administration's enforcement report for recall number records a recall of Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), sterile, 0.34 FL OZ (10 mL), distributed by The Mentholatum Company of Orchard Park, NY 14127, and made in Vietnam. The record lists UPC 310742011135 and NDC 10742-8162-1. The recalling firm is listed as The reason given is "." According to the enforcement record, the recall was initiated on July 14, 2026, and reported on July 29, 2026, covering 97,201 cartons distributed . The status is listed as , so the action is still developing. The affected lots listed in the record are: Lot # 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; and 5L2VA, 512VB 2028/11. The codes are reproduced here exactly as the enforcement record states them; the record repeats "512V" in one entry and its formatting of the final two entries is unclear, and no corrected version of those codes appears in the record. The product is an over-the-counter ophthalmic solution sold in a 10 mL (0.34 fl oz) bottle, according to the U.S. National Library of Medicine's DailyMed drug listing, which records its two active ingredients as povidone 0.68% and propylene glycol 0.3% in a water-based formula whose other listed components include purified water, boric acid and sodium borate, calcium chloride, magnesium sulfate, edetate disodium, poloxamer, polyoxyl stearate, PEG-10 castor oil, sesame oil, menthol and polyaminopropyl biguanide. It is a finished consumer retail item bought off the shelf without a prescription, so the people holding it are ordinary individual purchasers rather than manufacturers or compounders. The FDA classified the action as . By the agency's own definition, 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 FDA's enforcement database records no other enforcement action by this firm; that history is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:17current

    No new facts; text unchanged and source URLs for the enforcement record, drug listing and classification definition added to citations.

  2. Version 57 Aug 2026, 10:48

    Removed label handling/usage statements not present in the fact set and added the source URLs for the enforcement record, the drug listing and the FDA's recall classification definitions.

  3. Version 47 Aug 2026, 06:10

    Added the label's external-use-only and bottle-tip warnings from the DailyMed listing and trimmed the unsourced retail-channel detail; added headline and dek.

  4. Version 37 Aug 2026, 01:18

    Noted that the lot codes are reproduced verbatim from the enforcement record, including a repeated "512V" and unclear formatting in the final entries.

  5. Version 26 Aug 2026, 20:56

    Added a paragraph describing what the product is and how it is sold, sourced to DailyMed, and cited the source URLs.

  6. Version 16 Aug 2026, 16:22

    First published.

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