U.S. buyers of recalled Rohto Cooling Eye Drops may be covered by a proposed class action alleging Rohto-Mentholatum, Rohto Pharmaceutical and The Mentholatum Company labeled the drops “Sterile” when they lacked assurance of sterility. No class has been certified and there is nothing to file yet.
Allegations Only · No Settlement Yet
This article describes a class action complaint. The statements below are unproven allegations. Rohto-Mentholatum Co., Ltd., Rohto Pharmaceutical Co., Ltd. and The Mentholatum Company have not been found liable, there is no certified class, and nothing to claim at this time. This page is informational and is not legal advice.
What Is This About?
Two consumers, from California and Illinois, filed Heredia v. Rohto-Mentholatum Co., Ltd., No. 1:26-cv-02019, on September 17, 2026, in the U.S. District Court for the Western District of New York. The defendants are Rohto-Mentholatum Co., Ltd., the Vietnamese manufacturer; its Japanese parent, Rohto Pharmaceutical Co., Ltd.; and The Mentholatum Company, the U.S. distributor based in Orchard Park, New York.The suit follows the July 2026 recall of nearly 12 million cartons of Rohto Cooling Eye Drops, which the FDA classified as Class II over a “lack of assurance of sterility.” The plaintiffs allege the front of every carton promised the drops were “Sterile,” that eye drops must be sterile to be lawfully sold, and that they would not have bought the drops had they known. They also allege the recall was poorly publicized, with no clear way for consumers to get their money back.
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Who Could Be Covered?
The complaint proposes a nationwide class of everyone who bought the drops in the United States for personal use, not resale, from the start of the limitations period until class notice goes out. It also proposes three narrower groups: a multi-state consumer protection class of buyers in California, Florida, Illinois, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York and Washington, and separate California and Illinois classes.Those definitions are only proposals. The court has not certified any class, and the plaintiffs say the definitions may change.
What the Complaint Claims
The complaint pleads nine counts:- California’s Consumers Legal Remedies Act, Unfair Competition Law and False Advertising Law
- The Illinois Consumer Fraud and Deceptive Business Practices Act and the Illinois Uniform Deceptive Trade Practices Act
- The consumer protection statutes of the ten states in the multi-state class
- Breach of the implied warranty of merchantability, and California’s Song-Beverly Consumer Warranty Act
- Unjust enrichment, pleaded in the alternative
What the Plaintiffs Want
The complaint seeks actual, statutory and punitive damages, restitution, attorneys’ fees and interest. It also asks for a court-ordered recall notice program that reaches buyers more widely, and an offer of a full refund to all class members, including people who no longer have the drops. The California CLRA count currently seeks only an injunction; the complaint says it will add a damages demand if the defendants do not respond to a pre-suit notice letter.What Happens Next?
The case is assigned to U.S. District Judge Meredith A. Vacca. Under the Western District of New York’s alternative dispute resolution plan, it was automatically referred to mediation, and the parties will report on that at the initial scheduling conference. As of September 25, 2026, the docket showed a summons issued to The Mentholatum Company and motions for out-of-state plaintiffs’ lawyers to appear; no defendant had responded. The foreign defendants must still be served.There is nothing to file. Buyers who still have the drops should stop using them; the recall allows a refund at the store where they were bought.
Questions
Do I need to have kept the bottle or receipt to be part of the Rohto lawsuit?
Not to be covered by the proposed class, which is defined by purchase, not by what a buyer kept. The complaint specifically asks the court to order refunds for buyers who no longer have the drops. If the case ever settles, any claim process and its proof rules would be set then; keeping the carton, bottle or a photo of the lot code is a sensible precaution.
Does returning the drops to the store affect the lawsuit?
The complaint does not address buyers who already got a store refund. Returning recalled drops for a refund is the remedy the recall itself describes. How any past refund would be treated would depend on the terms of a future settlement or judgment, if there is one.
Does the lawsuit cover eye infections or injuries?
No. The complaint seeks economic losses — the price paid, or a price premium — for buyers of the drops. It does not assert personal-injury claims. Anyone with eye pain, discharge, persistent redness or vision changes should see a health care provider.
Is the Rohto lawsuit the same as the recall?
No. The recall is a voluntary action Rohto started in July 2026 and the FDA classified; the lawsuit is a separate private case by consumers. The recall's store-refund remedy is available regardless of the lawsuit.
Class Action Complaint
Sources
- Class action complaint, Heredia v. Rohto-Mentholatum Co., Ltd., No. 1:26-cv-02019 (W.D.N.Y. filed Sept. 17, 2026), ECF No. 1 (embedded above)
- CourtListener docket — Heredia v. Rohto-Mentholatum Co., Ltd.
- FDA Enforcement Report — recall event 99440
