FDA Recalls Over 12 Million Eye Drops Over Sterility Concerns

Before you put that next round of drops in your eyes, check the label.

The Food and Drug Administration has issued a report on a nationwide recall of millions of Rohto eye drops due to 'lack of assurance of sterility.' The recall carries Class II status, meaning the products may cause temporary, reversible effects, but serious health consequences are unlikely.

The drops were sold at major retailers like Walmart, Walgreens, and CVS, as well as online platforms like Amazon and Instacart.

A total of 12,460,649 bottles of Rohto Cooling Eye Drops are affected.

Recalled products were sold individually and in two-packs, and marketed with the brand names Rohto Cooling Eye Drops All-in-One, Rohto Cooling Eye Drops Max Strength, Rohto Cooling Eye Drops Optic Glow, Rohto Cooling Eye Drops Digi Eye, Rohto Cooling Eye Drops Dry Aid, Rohto Cooling Drops, and Rohto Cooling Eye Drops Cool Relief.

Check your products for these lot numbers and expiration dates:

Rohto Cooling Eye Drops All-in-One
3H1V, 2026/07; 3J1V, 3J2V, 2026/09; 3K1V, 2026/10; 4A1V, 4A2V, 2026/12; 4B1V, 4B2V, 2027/01; 4G1V, 4G2V, 4G3V, 2027/06; 4I1V, 4I2V, 4I2VA, 2027/08; 4J1V, 4J2V, 2027/09; 4K2V, 4K3V, 4K4V, 2027/10; 5B1V, 5B2V, 5B3V, 2028/01; 5D1V, 2028/03; 5E1V, 5E2V, 5E3V, 2028/04; 5H1V, 2028/07; 5I1V, 2028/08; 5J1V, 5J2V, 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V, 2028/11; 6A1V, 6A2V, 2028/12; 6B1V, 2029/01; 6C1V, 2029/02

Rohto Cooling Eye Drops Max Strength
3H2V, 3H3V, 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, 2026/09; 3K1V, 3K2V, 2026/10; 4A2V, 2026/12; 4B1V, 4B2V, 4B3V, 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, 2027/06; 4H1V, 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, 2027/08

Rohto Cooling Eye Drops Max Strength Twin Pack
3H1V, 2026/07; 3J2V, 2026/09; 4A1V, 4A1VA, 2026/12; 4G1V, 2027/06; 4I3V, 2027/08; 5A1V, 2027/12; 5B3V, 2028/01; 5G3V, 2028/06; 5J1V, 2028/09; 5L1V, 2028/11; 6A1V, 2028/12; 6B4V, 2029/01; 6C2V, 2029/02

Rohto Cooling Eye Drops Optic Glow
3H1V, 3H1VA, 2025/07; 3J1V, 3J2V, 2025/09; 3K1V, 2025/10; 4F1V, 2027/05; 4F1VA, 2027/05; 4H1V, 2027/07; 4I1V, 2027/08; 4K1V, 4K2V, 2027/10; 5A1V, 5A2V, 2027/12; 5D1V, 2028/03; 5E1V, 2028/04; 5J1V, 5J2V, 2028/09; 6B1V, 2029/01; 6C1V, 6C1VA, 6C1VB, 2029/02

Rohto Cooling Eye Drops Digi Eye
4B1V, 4B1VA, 2027/01; 4J1V, 2027/09

Rohto Cooling Eye Drops Dry Aid
4G1VA, 2027/06; 4J1VA, 2027/09; 5A1V, 2027/12; 5D1VA, 2028/03; 5G1VA, 2028/06; 512V, 512V, 512VB, 2028/08; 5L2VA, 512VB, 2028/11

Rohto Cooling Eye Drops Dry Aid Twin Pack
4G1V, 2027/06; 4J1V, 512VB, 2027/09; 5D1V, 2028/03; 5G1V, 512VB, 2028/06; 512V, 512VB, 2028/08

Rohto Cooling Eye Drops Cool Relief
3J1V, 2026/09; 4A1V, 2026/12; 4G1V, 4G2V, 2027/06; 4I1V, 2027/08; 4JIV, 2027/09; 5A1V, 2027/12 ; 5B1V, 2028/01; 5F1V, 2028/05; 5F1VA, 2028/05; 5H1V, 5H1VA, 2028/07; 5J1V, 5J1VA, 2028/09; 5L1V, 2028/11; 6B1V, 2029/01

Do not use recalled eye drops; instead, dispose of them or return them to their place of purchase. If you experience symptoms after using recalled eye drops, contact your healthcare provider.