FDA Issues Nationwide Recall of Nearly 12 Million Bottles of Rohto Eye Drops Due to Sterility Concerns

The U.S. Food and Drug Administration has announced a recall of approximately 11.96 million bottles of Rohto eye drops, citing concerns over sterility that may pose health risks to consumers.

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall of approximately 11,960,623 bottles of Rohto eye drops due to significant concerns regarding sterility that could potentially jeopardize consumer health. Announced on July 30, 2026, the recall encompasses multiple variants of Rohto Cooling Eye Drops, which have been widely distributed across retail locations in the United States.

Background of the Recall

The recall arises from a classification by the FDA indicating a lack of assurance regarding the sterility of the affected products. This situation has been classified as a Class II recall, implying that while the products may pose a risk of causing “temporary” or “reversible” health effects, they do not necessarily lead to serious health consequences. Nevertheless, the FDA has urged consumers to take the recall seriously and to verify their products against the provided recall information.

Details of the Affected Products

The recalled products include nine distinct types of Rohto Cooling Eye Drops, all distributed by The Mentholatum Company. The following table outlines the specific products affected, alongside their respective UPC codes, lot numbers, and expiration dates:

• Rohto Cooling Eye Drops ALL-IN-ONE (0.4 fl oz) – UPC: 310742010862; Lot Codes: 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; Expiration Dates: Various from July 2026 to February 2029.
• Rohto Cooling Eye Drops Max Strength (0.4 fl oz) – UPC: 310742011012; Lot Codes: 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; Expiration Dates: Various from July 2026 to August 2027.
• Rohto Cooling Eye Drops Max Strength Twin Pack – UPC: 310742011210; Lot Codes: 3H1V, 3J2V, 4A1V, 4A1VA, 4G1V, 4I3V, 5A1V, 5B3V, 5G3V, 5J1V, 5L1V, 6A1V, 6B4V, 6C2V; Expiration Dates: Various from July 2026 to February 2029.
• Rohto Cooling Eye Drops Optic Glow (0.4 fl oz) – UPC: 310742010916; Lot Codes: 3H1V, 3H1VA, 3J1V, 3J2V, 3K1V, 4F1V, 4F1VA, 4H1V, 4I1V, 4K1V, 4K2V, 5A1V, 5A2V, 5D1V, 5E1V, 5J1V, 5J2V, 6B1V, 6C1V, 6C1VA, 6C1VB; Expiration Dates: Various from July 2025 to February 2029.
• Rohto Cooling Eye Drops Digi Eye (0.4 fl oz) – UPC: 310742010602; Lot Codes: 4B1V, 4B1VA, 4J1V; Expiration Dates: January 2027, September 2027.
• Rohto Cooling Eye Drops Dry Aid (0.34 fl oz) – UPC: 310742011135; Lot Codes: 4G1VA, 4J1VA, 5A1V, 5D1VA, 5G1VA, 5I2V, 5I2VB, 5L2VA; Expiration Dates: Various from June 2027 to November 2028.
• Rohto Cooling Eye Drops Dry Aid Twin Pack – UPC: 310742011159; Lot Codes: 4G1V, 4J1V, 5D1V, 5G1V, 5I2V, 5I2VB; Expiration Dates: Various from June 2027 to November 2028.
• Rohto Cooling Eye Drops Cool Relief (0.4 fl oz) – UPC: 310742010749; Lot Codes: 3J1V, 4A1V, 4G1V, 4G2V, 4I1V, 4J1V, 5A1V, 5B1V, 5F1V, 5F1VA, 5H1V, 5H1VA, 5J1V, 5J1VA, 5L1V, 6B1V; Expiration Dates: Various from September 2026 to February 2029.

Health Risks and Consumer Guidance

The FDA has strongly recommended that consumers check their eye drop products against the recall information provided. If consumers find that they have purchased any affected products, they are advised to either return these items to the place of purchase for a full refund or dispose of them safely to mitigate any potential health risks. The recall stems from concerns that the affected eye drops may lead to infections or other adverse health effects due to potential contamination.

While the FDA has classified this recall as Class II, indicating that most health risks are temporary or reversible, the agency has emphasized the importance of seeking medical attention if any consumers experience adverse effects after using the recalled eye drops. Symptoms that may arise from contaminated eye drops include redness, irritation, or other eye-related ailments.

Consumer Contact Information

For additional questions regarding this recall, consumers are encouraged to reach out to the FDA at 1-888-INFO-FDA (1-888-463-6332). The agency continues to stress the importance of vigilance among consumers regarding product safety and recalls that may affect their health.

Implications for Product Safety and Regulation

This recall highlights ongoing concerns regarding product safety in the consumer health market, particularly for over-the-counter medications. As eye care products are critical to public health, this incident underscores the necessity for stringent quality control and monitoring practices by manufacturers. The FDA’s response to this situation reflects its commitment to consumer safety and regulatory oversight, ensuring that products available in the market meet established safety standards.

In recent years, the FDA has increased its scrutiny of health products, particularly following high-profile recalls and contamination cases. This recall serves as a reminder of the importance of robust manufacturing processes and the need for transparency in reporting safety concerns. As consumers become more aware of their rights and the potential risks associated with health products, manufacturers may face greater pressure to maintain high safety standards.