FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Cool Relief recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops recalled for sterility concerns
Rohto Cooling Eye Drops Cool Relief may not meet sterility standards required for eye medications. The affected product was manufactured in Vietnam and distributed nationwide. No injuries have been reported to date.
- Check your eye drops bottle for one of the affected lot numbers (3J1V through 6B1V with expiration dates between 2026/09 and 2029/01).
- Stop using the product if you have one of the affected lots.
- Contact your pharmacist or eye care provider if you have used this product and have eye discomfort or changes in vision.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
2910148 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0722-2026More 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 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
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Optic Glow recalled for lack of sterility assurance
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