What Happened to Rohto Eye Drops Recall (July 2026)?
Rohto Eye Drops faced a significant Class II recall in July 2026, affecting nearly 12 million cartons of various Rohto Cooling Eye Drops due to concerns over sterility. This follows an earlier sterility-related recall in January 2014, though no illnesses have been reported in connection with the 2026 event.
Quick Answer
In July 2026, Rohto-Mentholatum (Vietnam) Co., Ltd. initiated a voluntary recall of nearly 12 million cartons of eight varieties of Rohto Cooling Eye Drops across the United States. The U.S. Food and Drug Administration (FDA) classified this as a Class II recall, citing a 'lack of assurance of sterility' in the products. Consumers are advised to immediately stop using affected products, which include popular lines like Rohto Cooling Eye Drops Max Strength and All-In-One. As of July 29, 2026, no illnesses have been reported in connection with this recall.
📊Key Facts
📅Complete Timeline9 events
First Sterility Recall for Rohto Eye Drops
The Mentholatum Company, a subsidiary of Rohto Pharmaceutical, initiated a voluntary recall of certain lots of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drops manufactured in Vietnam due to potential sterility concerns. No injuries were reported.
FDA Recall Alert Issued
The FDA issued an alert regarding the Rohto eye drops recall, confirming it was due to a manufacturing review at the Vietnam facility involving sterility controls.
FDA Warning on Unregistered Rohto Vita Eye Drop (Philippines)
The Philippine FDA issued a public health warning against the purchase and use of unregistered 'ROHTO VITA EYE DROP (IN FOREIGN CHARACTERS),' noting it had not undergone evaluation processes.
Broader Eye Drop Contamination Warnings (Not Rohto-Branded)
The FDA issued a widespread warning against 26 over-the-counter eye drop products from various brands (e.g., CVS Health, Rite Aid, Target Up & Up) due to unsanitary manufacturing conditions and bacterial contamination, leading to serious infections, vision loss, and deaths. Rohto-branded products were not listed in this specific warning.
Rohto Pharmaceutical Co. Reports Strong Q4 2026 Earnings
Rohto Pharmaceutical Co. Ltd. announced record-high net sales and operating income for Q4 2026, outperforming forecasts, driven by strong domestic and overseas sales.
Rohto-Mentholatum (Vietnam) Initiates New Recall
Rohto-Mentholatum (Vietnam) Co., Ltd. voluntarily initiated a recall of multiple Rohto Cooling Eye Drops products due to a lack of assurance of sterility.
California State Board of Pharmacy Issues Recall Alert
The California State Board of Pharmacy included 'The Mentholatum Company, Rohto Eye Drops' in its recall subscriber alert emails, indicating the recall's reach.
FDA Classifies Rohto Eye Drops Recall as Class II
The U.S. Food and Drug Administration officially classified the recall of nearly 12 million cartons of Rohto Cooling Eye Drops as a Class II event, meaning the products may cause temporary or reversible adverse health consequences.
Widespread News Coverage and Consumer Warnings
News outlets widely report on the Rohto Eye Drops recall, detailing the affected products and advising consumers to stop use immediately. No illnesses have been reported in connection with this recall.
🔍Deep Dive Analysis
Rohto Pharmaceutical Co., Ltd., a prominent Japanese multinational, has been a significant player in the global eye care market for decades. However, the company's reputation for quality control came under scrutiny with a major product recall in July 2026. This recall, initiated by its Vietnamese manufacturing arm, Rohto-Mentholatum (Vietnam) Co., Ltd., and distributed by The Mentholatum Company in the U.S., involved nearly 12 million cartons of various Rohto Cooling Eye Drops.
The U.S. Food and Drug Administration (FDA) classified the July 2026 action as a Class II recall on July 23, 2026. The primary reason cited was a 'lack of assurance of sterility,' a critical concern for ophthalmic products applied directly to the eye. The recall impacted eight distinct varieties, including Rohto Cooling Eye Drops All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, sold individually and in two-pack sets nationwide. While Class II recalls indicate that products may cause temporary or reversible adverse health consequences, or that the probability of serious harm is remote, the sheer volume of affected products underscored the seriousness of the manufacturing oversight.
Fortunately, as of July 29, 2026, no illnesses or adverse events have been reported in connection with this specific recall. Consumers who possess affected lot numbers are advised to discontinue use immediately and can dispose of the drops or return them to the place of purchase. The company has not released a public press statement with instructions, but the FDA's enforcement report provides details.
This is not the first time Rohto eye drops have faced sterility concerns. In January 2014, The Mentholatum Company voluntarily recalled certain lots of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drops, also manufactured in Vietnam, due to potential sterility issues. Similar to the 2026 event, that recall was initiated out of an abundance of caution, and no injuries or adverse effects were reported at the time.
Despite these recalls, Rohto Pharmaceutical Co. continues to operate as a global entity, manufacturing and selling a wide range of health and beauty care products. As of March 31, 2026, the company reported a trailing 12-month revenue of $2.28 billion, with strong financial performance and growth in both domestic and overseas markets. The company emphasizes its commitment to safety and rigorous testing, operating within FDA-inspected facilities that adhere to Current Good Manufacturing Practices (CGMPs). However, recurring sterility issues highlight the ongoing challenges in maintaining consistent quality control across complex global supply chains, particularly for sensitive pharmaceutical products.
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