FDA Recalls 12 Million Over-the-Counter Eye Drops Nationwide

Chloe JoeTue, July 28, 2026 at 10:26 AM UTC

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Millions of OTC Eye Drops Recalled NationwideJelena Lalic - Getty Images

You may want to check your eye drops before administering your next dose. The Food and Drug Administration (FDA) has issued a report on a nationwide recall of millions of Rohto eye drops due to “lack of assurance of sterility.”

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.

The FDA has labeled the recall as a Class II, meaning recalled products may cause temporary, reversible effects, and serious health consequences are unlikely.

Here, how to tell if you have recalled eye drops, and what to do with affected products.

How to identify recalled eye drops

Check your products for the lot numbers and associated expiration dates listed below.

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

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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

What to do with affected products

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.

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