FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Dry Aid recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops recalled for sterility issue
Rohto Cooling Eye Drops Dry Aid (twin pack) distributed nationwide may not meet sterility requirements. The affected lots were manufactured in Vietnam and distributed by The Mentholatum Company. No injuries have been reported.
- Check your eye drops for one of the affected lot numbers: 4G1V (exp. June 2027), 4J1V (exp. Sept. 2027), 5D1V (exp. March 2028), 5G1V (exp. June 2028), or 512V (exp. Aug. 2028).
- Stop using the product if you have an affected lot.
- Speak to a pharmacist or eye care provider if you have used this product and have eye discomfort or irritation.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
353 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0721-2026More Rohto-Mentholatum (Vietnam) Co., Ltd. recalls
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Cool Relief recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Digi Eye recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Dry Aid recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
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