Rohto Cooling Eye Drops Dry Aid Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The Mentholatum Company is recalling 353 cartons of Rohto Cooling Eye Drops Dry Aid due to lack of assurance of sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Rohto-Mentholatum (Vietnam) Co., Ltd. initiated a voluntary recall of Rohto Cooling Eye Drops Dry Aid after the FDA classified it as Class II for lack of assurance of sterility. The recall is ongoing and was initiated by letter.
Which Products Are Affected
The affected product is Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam. UPC: 310742011159, NDC: 10742-8162-2. Quantity: 353 cartons. Lot numbers: 4G1V (Exp 2027/06); 4J1V, 512VB (2027/09); 5D1V (2028/03); 5G1V, 512VB (2028/06); 512V, 512VB (2028/08). Distributed nationwide within the United States.
What You Should Do
Consumers should stop using the recalled product and contact the recalling firm for return or refund instructions.
Why This Matters
Lack of sterility assurance in an ophthalmic product may pose a risk of infection.
Source
FDA recall number D-0721-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,011 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.