Rohto Eye Drops Recalled Nationwide: Over 11 Million Bottles Pulled Over Sterility Concerns
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of more than 11 million bottles of Rohto Cooling Eye Drops due to a "lack of assurance of sterility." The voluntary recall, initiated on July 14, 2026, by manufacturer Rohto-Mentholatum (Vietnam) Co., Ltd., affects eight popular over-the-counter eye drop products distributed by The Mentholatum Company
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The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of more than 11 million bottles of Rohto Cooling Eye Drops due to a "lack of assurance of sterility." The voluntary recall, initiated on July 14, 2026, by manufacturer Rohto-Mentholatum (Vietnam) Co., Ltd., affects eight popular over-the-counter eye drop products distributed by The Mentholatum Company .
The Scope of the Recall: Millions of Bottles Affected
The recall is one of the largest of its kind in recent years. According to the FDA's enforcement report, approximately 11,960,623 cartons of Rohto Cooling Eye Drops have been recalled nationwide . The affected products were manufactured in Vietnam and distributed across the United States.
The FDA has classified the recall as Class II, meaning that use of the products may cause temporary or reversible adverse health consequences, while the probability of serious harm is considered remote .
Which Rohto Eye Drops Are Being Recalled?
Eight distinct Rohto Cooling Eye Drop products are included in the recall, spanning multiple formulations and sold in both single and twin-packs :
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| Product Name | UPC | Affected Lot Codes | Expiration Dates |
|---|---|---|---|
| Rohto Cooling Eye Drops ALL-IN-ONE | 310742010862 | 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 | 2026/07 through 2029/02 |
| Rohto Cooling Eye Drops Max Strength | 310742011012 | 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 | 2026/07 through 2027/08 |
| Rohto Cooling Eye Drops Max Strength Twin Pack | 310742011210 | 3H1V; 3J2V; 4A1V, 4A1VA; 4G1V; 4I3V; 5A1V; 5B3V; 5G3V; 5J1V; 5L1V; 6A1V; 6B4V; 6C2V | 2026/07 through 2029/02 |
| Rohto Cooling Eye Drops Optic Glow | 310742010916 | 3H1V, 3H1VA; 3J1V, 3J2V; 3K1V; 4F1V, 4F1VA; 4H1V; 4I1V; 4K1V, 4K2V; 5A1V, 5A2V; 5D1V; 5E1V; 5J1V, 5J2V; 6B1V; 6C1V, 6C1VA, 6C1VB | 2025/07 through 2029/02 |
| Rohto Cooling Eye Drops Digi Eye | 310742010602 | 4B1V, 4B1VA; 4J1V | 2027/01; 2027/09 |
| Rohto Cooling Eye Drops Dry Aid | 310742011135 | 4G1VA; 4J1VA; 5A1V; 5D1VA; 5G1VA; 5I2V, 5I2VB; 5L2VA | 2027/06 through 2028/11 |
| Rohto Cooling Eye Drops Dry Aid Twin Pack | 310742011159 | 4G1V; 4J1V; 5D1V; 5G1V; 5I2V, 5I2VB | 2027/06 through 2028/08 |
| Rohto Cooling Eye Drops Cool Relief | 310742010749 | 3J1V; 4A1V; 4G1V, 4G2V; 4I1V; 4J1V; 5A1V; 5B1V; 5F1V, 5F1VA; 5H1V, 5H1VA; 5J1V, 5J1VA; 5L1V; 6B1V | 2026/09 through 2029/01 |
The Risk: A "Lack of Assurance of Sterility"
The recall was issued because the manufacturer could not guarantee that the products were sterile . Eye drops must be sterile, as they are applied directly to the eye, and contamination could lead to serious infections, irritation, and in severe cases, vision loss .
The FDA noted that the issue was a potential risk rather than a confirmed contamination event. No illnesses or injuries have been reported to date .
What Should Consumers Do?
Anyone who has purchased a Rohto Cooling Eye Drop product should:
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Check their products immediately against the UPC and lot number list provided above.
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Stop using any affected product immediately .
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Dispose of the product or return it to the place of purchase for a refund .
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Contact a healthcare provider if they experience any adverse effects, such as eye redness, pain, or blurred vision .
Adverse effects can be reported to the FDA's MedWatch program at fda.gov/safety/medwatch or by calling 1-800-FDA-1088 .
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