Rohto Cooling Eye Drops Digi Eye 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 FDA announced a Class II recall of Rohto Cooling Eye Drops Digi Eye due to lack of assurance of sterility, affecting 65,219 cartons distributed nationwide in the United States.
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 Digi Eye due to lack of assurance of sterility. The recall is classified as Class II by the FDA and remains ongoing.
Which Products Are Affected
- Product: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)
- Distributed by: The Mentholatum Company, Orchard Park, NY 14127
- Made in Vietnam
- UPC: 310742010602
- NDC: 10742-8175-1
- Quantity: 65,219 cartons
- Lots: 4B1V, 4B1VA (Exp. Date 2027/01); 4J1V (Exp. Date 2027/09)
- Distribution: Nationwide within the United States
- Recall Number: D-0719-2026
What You Should Do
Consumers should check product lots and expiration dates against the listed information. No specific return or contact instructions are provided in the recall notice.
Why This Matters
The recall affects a widely distributed over-the-counter ophthalmic product across the United States, raising potential concerns about product sterility for eye care use.
Source
FDA recall D-0719-2026. Data from FDA enforcement report.
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 (1,134 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.