More than 12,460,649 bottles of over-the-counter Rohto eye drops are being removed from shelves across the country after federal regulators identified sterility concerns, the Food and Drug Administration announced.
The recall involves 12,460,649 units sold under seven brand names: Rohto Cooling Eye Drops All-in-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, Cooling Drops, and Cool Relief. These products were available individually and in two-packs.
The FDA labeled the recall as Class II, indicating the recalled products may cause temporary, reversible effects, and serious health consequences are unlikely.
How to check if your eye drops are affected
Shoppers should examine the lot numbers and expiration dates printed on the packaging. The recalled items include multiple variants and packaging types.
For Rohto Cooling Eye Drops All-in-One, affected lots include 3H1V (expiring July 2026), 3J1V and 3J2V (September 2026), and 4A1V through 6C1V, with expiration dates extending from December 2026 to February 2029.
Max Strength versions are recalled under lot numbers 3H2V, 3H3V (July 2026), 3J1V through 3K2V (September–October 2026), and others up to 4I5V (August 2027). The Max Strength Twin Pack is also included, with lots like 3H1V (July 2026) and 5L1V (November 2028).
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Other recalled products include Optic Glow (lot numbers 3H1V to 6C1VB), Digi Eye (4B1V, 4J1V), Dry Aid (4G1VA, 512V), and Cool Relief (3J1V, 5L1V). A complete list of lot numbers and expiration dates can be found on the FDA’s website.
If a product matches any of these details, the agency recommends discontinuing use immediately.
What to do with recalled eye drops
Consumers should throw away the affected products or return them to the store where they were bought.
If you experience symptoms after using recalled eye drops, contact your healthcare provider.
The agency has not said whether more batches will be tested or if the recall will grow. Most affected lots expire within two years, though some extend to early 2029.
Health experts note that while the risk is minimal, users should remain cautious. Temporary issues from contaminated products can still disrupt daily life.
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