Rohto Cooling Eye Drops 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 has issued a Class II recall for Rohto Cooling Eye Drops Cool Relief due to lack of assurance of sterility, affecting 2,910,148 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 Mentholatum Company initiated a voluntary recall of Rohto Cooling Eye Drops Cool Relief due to lack of assurance of sterility.
Which Products Are Affected
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL), NDC 10742-8141-1, UPC 310742010749. Affected lots include: 3J1V (Exp. 2026/09); 4A1V (Exp. 2026/12); 4G1V, 4G2V (Exp. 2027/06); 4I1V (Exp. 2027/08); 4JIV (Exp. 2027/09); 5A1V (Exp. 2027/12); 5B1V (Exp. 2028/01); 5F1V, 5F1VA (Exp. 2028/05); 5H1V, 5H1VA (Exp. 2028/07); 5J1V, 5J1VA (Exp. 2028/09); 5L1V (Exp. 2028/11); 6B1V (Exp. 2029/01). A total of 2,910,148 cartons are affected. The recalling firm is Rohto-Mentholatum (Vietnam) Co., Ltd. Distribution was nationwide within the United States. Recall number D-0722-2026.
What You Should Do
Consumers should check product lot numbers and expiration dates against the listed affected codes.
Why This Matters
The recall involves a widely distributed over-the-counter ophthalmic product across the United States.
Source
FDA recall D-0722-2026
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 (1,112 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.