Rohto Cooling Eye Drops ALL-IN-ONE 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 ALL-IN-ONE due to lack of assurance of sterility, affecting over 1 million cartons distributed nationwide.
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
The recall was initiated due to lack of assurance of sterility for the affected eye drops.
Which Products Are Affected
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL). Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam. UPC 310742010862, NDC 10742-8146-1. A total of 1,033,266 cartons are affected. Recall number D-0715-2026. Distribution pattern: Nationwide within the United States. Lot numbers: 3H1V (Exp. 2026/07); 3J1V, 3J2V (Exp. 2026/09); 3K1V (Exp. 2026/10); 4A1V, 4A2V (Exp. 2026/12); 4B1V, 4B2V (Exp. 2027/01); 4G1V, 4G2V, 4G3V (Exp. 2027/06); 4I1V, 4I2V, 4I2VA (Exp. 2027/08); 4J1V, 4J2V (Exp. 2027/09); 4K2V, 4K3V, 4K4V (Exp. 2027/10); 5B1V, 5B2V, 5B3V (Exp. 2028/01); 5D1V (Exp. 2028/03); 5E1V, 5E2V, 5E3V (Exp. 2028/04); 5H1V (Exp. 2028/07); 5I1V (Exp. 2028/08); 5J1V, 5J2V (Exp. 2028/09); 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V (Exp. 2028/11); 6A1V, 6A2V (Exp. 2028/12); 6B1V (Exp. 2029/01); 6C1V (Exp. 2029/02). Recalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
What You Should Do
Consumers should check product lot numbers against the listed recall codes.
Why This Matters
The recall involves over one million cartons of eye drops distributed nationwide in the United States.
Source
FDA recall number D-0715-2026. Agency: FDA.
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 (1,397 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.