People who bought Rohto Cooling Eye Drops ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid or Cool Relief from lots expiring July 2025 through February 2029 can return them to the store for a refund. Rohto-Mentholatum recalled 11.96 million cartons over a lack of sterility assurance, so the drops should not be used.
What Is Being Recalled?
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling eight Rohto Cooling Eye Drops products sold across the United States because of a "lack of assurance of sterility," according to the FDA's enforcement report. The drops were made in Vietnam and distributed by The Mentholatum Company of Orchard Park, New York. The recall was started by the company on July 14, 2026, and the FDA classified it as a Class II recall on July 23, 2026.A total of 11,960,623 cartons are covered, the large majority of them Rohto Cooling Eye Drops Max Strength (6.08 million cartons) and Cool Relief (2.91 million cartons). Eye drops are sold as sterile products because they go directly onto the surface of the eye; when a manufacturer cannot show that its process reliably keeps them sterile, the product is pulled even if no contamination has been found.
The practical answer for consumers is to stop using the drops. Recall coverage reports that they can throw the product away or take it back to the store where it was bought for a full refund. There is no online refund form or registration site for this recall.
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Which Rohto Products Are Included?
The FDA lists each product under its own recall number. Every one is labeled "Sterile," comes in a 13 mL (0.4 fl oz) bottle except the 10 mL (0.34 fl oz) Dry Aid, and names The Mentholatum Company as distributor.| Product | UPC | Cartons | Expiration dates |
|---|---|---|---|
| Rohto Cooling Eye Drops Max Strength | 310742011012 | 6,076,306 | July 2026 – August 2027 |
| Rohto Cooling Eye Drops Cool Relief | 310742010749 | 2,910,148 | September 2026 – January 2029 |
| Rohto Cooling Eye Drops Optic Glow | 310742010916 | 1,278,457 | July 2025 – February 2029 |
| Rohto Cooling Eye Drops ALL-IN-ONE | 310742010862 | 1,033,266 | July 2026 – February 2029 |
| Rohto Cooling Eye Drops Max Strength Twin Pack | 310742011210 | 499,673 | July 2026 – February 2029 |
| Rohto Cooling Eye Drops Dry Aid | 310742011135 | 97,201 | June 2027 – November 2028 |
| Rohto Cooling Eye Drops Digi Eye | 310742010602 | 65,219 | January 2027 – September 2027 |
| Rohto Cooling Eye Drops Dry Aid Twin Pack | 310742011159 | 353 | June 2027 – August 2028 |
Lot numbers, as listed by the FDA
The lot code and expiration date are printed on the carton and the bottle. Lot codes below are reproduced as they appear in the FDA enforcement report, including a few that appear to use the digit 1 where the letter I is meant (for example, "512V"); check both readings against your bottle.- Max Strength (NDC 10742-8158-1, recall D-0716-2026): 3H2V, 3H3V, 3J1V, 3J3V, 3J4V, 3J5V, 3K1V, 3K2V, 4A2V, 4B1V, 4B2V, 4B3V, 4F1V, 4F2V, 4F3V, 4F4V, 4G2V, 4G3V, 4G4V, 4G5V, 4H1V, 4I1V, 4I2V, 4I4V, 4I5V.
- Cool Relief (NDC 10742-8141-1, recall D-0722-2026): 3J1V, 4A1V, 4G1V, 4G2V, 4I1V, 4JIV, 5A1V, 5B1V, 5F1V, 5F1VA, 5H1V, 5H1VA, 5J1V, 5J1VA, 5L1V, 6B1V.
- Optic Glow (NDC 10742-8160-1, recall D-0718-2026): 3H1V, 3H1VA, 3J1V, 3J2V, 3K1V, 4F1V, 4F1VA, 4H1V, 4I1V, 4K1V, 4K2V, 5A1V, 5A2V, 5D1V, 5E1V, 5J1V, 5J2V, 6B1V, 6C1V, 6C1VA, 6C1VB.
- ALL-IN-ONE (NDC 10742-8146-1, recall D-0715-2026): 3H1V, 3J1V, 3J2V, 3K1V, 4A1V, 4A2V, 4B1V, 4B2V, 4G1V, 4G2V, 4G3V, 4I1V, 4I2V, 4I2VA, 4J1V, 4J2V, 4K2V, 4K3V, 4K4V, 5B1V, 5B2V, 5B3V, 5D1V, 5E1V, 5E2V, 5E3V, 5H1V, 5I1V, 5J1V, 5J2V, 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V, 6A1V, 6A2V, 6B1V, 6C1V.
- Max Strength Twin Pack (NDC 10742-8158-2, recall D-0717-2026): 3H1V, 3J2V, 4A1V, 4A1VA, 4G1V, 4I3V, 5A1V, 5B3V, 5G3V, 5J1V, 5L1V, 6A1V, 6B4V, 6C2V.
- Dry Aid (NDC 10742-8162-1, recall D-0720-2026): 4G1VA, 4J1VA, 5A1V, 5D1VA, 5G1VA, 512V, 512VB, 5L2VA.
- Digi Eye (NDC 10742-8175-1, recall D-0719-2026): 4B1V, 4B1VA, 4J1V.
- Dry Aid Twin Pack (NDC 10742-8162-2, recall D-0721-2026): 4G1V, 4J1V, 5D1V, 5G1V, 512V, 512VB.
Why Sterility Matters for Eye Drops
Microorganisms introduced into the eye can cause infections, and the eye's surface has little defense against a contaminated product applied to it several times a day. That is why the FDA treats a gap in sterility controls as a reason to recall even without a confirmed contaminated bottle. The Class II label means the FDA considers temporary or medically reversible health effects possible and serious harm unlikely.Anyone who used the drops and has eye pain, redness that does not clear up, discharge, light sensitivity or blurred vision should contact an eye doctor or other health care provider. Adverse reactions can be reported to the FDA's MedWatch program. The same caution applied in earlier eye drop recalls that led to litigation, including the EzriCare artificial tears infection cases and the prescription Lupin prednisolone eye drops recall.
A Lawsuit Has Been Filed
Federal court records show a proposed class action captioned Heredia v. Rohto-Mentholatum Co., Ltd., No. 1:26-cv-02019, was filed September 17, 2026, in the U.S. District Court for the Western District of New York, the federal court whose territory includes Mentholatum’s Orchard Park headquarters. The docket names three defendants — Rohto-Mentholatum Co., Ltd., Rohto Pharmaceutical Co., Ltd. and The Mentholatum Company — and shows the plaintiffs suing on behalf of themselves and all others similarly situated, with a jury demand. The case is assigned to U.S. District Judge Meredith A. Vacca and, under the court’s standard alternative dispute resolution plan, was automatically referred to mediation. The docket lists the cause as diversity fraud, but the complaint itself had not been posted publicly as of September 25, 2026, so its specific claims and proposed class definition could not be reviewed from the filing.Any claims in the case are allegations only. No class has been certified, no court has found Rohto-Mentholatum or any related company liable, and there is no settlement or claim form. Nothing needs to be filed now. Buyers who want a record of their purchase can keep the carton, the bottle or a photo of the lot code, along with any receipt. A separate eye-care labeling suit is pending against a different company over Alcon Systane preservative-free drops.
Questions
How can I tell whether my Rohto eye drops are part of the recall?
The recall covers eight Rohto Cooling Eye Drops products: ALL-IN-ONE, Max Strength, Max Strength Twin Pack, Optic Glow, Digi Eye, Dry Aid, Dry Aid Twin Pack and Cool Relief, all made in Vietnam and distributed by The Mentholatum Company. Compare the product name, UPC, lot number and expiration date printed on the carton or bottle with the FDA enforcement report. Recalled lots carry expiration dates from July 2025 through February 2029.
What should I do with recalled Rohto Cooling Eye Drops?
Stop using them. Recall coverage reports that consumers can either throw the drops away or return them to the store where they bought them for a full refund. There is no online refund form or registration site for this recall.
Have any injuries been linked to the recalled Rohto drops?
The FDA’s enforcement report does not describe any reported injuries; the stated reason is a lack of assurance of sterility, not confirmed contamination. The FDA placed the recall in Class II, its category for products that may cause temporary or medically reversible health problems where serious harm is unlikely. Anyone with eye pain, redness that does not clear, discharge or vision changes after using the drops should contact a health care provider, and problems can be reported to the FDA through MedWatch.
Is there a lawsuit over the Rohto eye drops recall?
Federal court records show a case captioned Heredia v. Rohto-Mentholatum Co., Ltd., No. 1:26-cv-02019, was filed September 17, 2026, in the U.S. District Court for the Western District of New York as a proposed class action against Rohto-Mentholatum Co., Ltd., Rohto Pharmaceutical Co., Ltd. and The Mentholatum Company. The complaint itself had not been posted publicly as of September 25, 2026. No class has been certified, no court has found the companies liable, and there is nothing to file.
Are other Rohto or Mentholatum products included?
The FDA enforcement report for this recall lists only the eight Rohto Cooling Eye Drops products made in Vietnam, identified by UPC, NDC, lot number and expiration date. A Rohto product that is not on that list is not part of this recall.
Sources
- FDA Enforcement Report — recall numbers D-0715-2026 through D-0722-2026 (event 99440): products, UPCs, NDCs, lot codes, carton counts, initiation and classification dates.
- Rohto Pharmaceutical notice on the voluntary U.S. recall of Vietnamese-made eye drops
- Fox Business — Rohto eye drops recalled over sterility concerns
- CourtListener — Heredia v. Rohto-Mentholatum Co., Ltd., No. 1:26-cv-02019 (W.D.N.Y.)
This page is informational and is not legal or medical advice.
