11M eye drop cartons recalled nationwide
Jul 31, 2026
More than 11 million cartons of Rohto Cooling Eye Drops have been recalled nationwide. The Food and Drug Administration said it’s over concerns they are sterile.
The Class II recall the FDA issued on July 23 does not affect all products, only select lot numbers printed on the packaging of eigh
t Rohto Cooling Eye Drops varieties. While no illnesses have been reported, the FDA said the affected products may cause ‘temporary’ or ‘reversible’ health effects, but ‘serious consequences are considered unlikely’.
The drops were manufactured by Rohto-Mentholatum in Vietnam and distributed by The Mentholatum Company of Orchard Park, New York.
Select lots of the following Rohto Cooling Eye Drops varieties are included in the recall:
•Rohto Cooling Eye Drops All-In-One (1,033,266 cartons)
•Rohto Cooling Eye Drops Max Strength (6,076,306 cartons of single variety and 499,673 cartons of twin pack)
•Rohto Cooling Eye Drops Optic Glow (1,278,457 cartons)
• Rohto Cooling Eye Drops Digi Eye (65,219 cartons)
•Rohto Cooling Eye Drops Dry Aid (97,201 cartons of single variety and 353 cartons of twin pack)
•Rohto Cooling Eye Drops Cool Relief (2,910,148 cartons)
The FDA says customers should stop using the product immediately if their lot number is included in the recall. Customers can dispose of the drops or return them to the place of purchase.
For questions about this recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).
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