FDA Recalls Nearly 12 Million Rohto Cooling Eye Drops Nationwide Over Sterility Concerns

The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of approximately 11,960,623 bottles of Rohto Cooling eye drops, distributed by The Mentholatum Company, due to concerns about product sterility. The recall has been classified as a Class II recall, meaning use of the affected products may cause temporary or reversible health effects. Consumers should stop using any matching products and check bottles against the detailed UPC, lot code and expiration information below.

Affected Products

The recall covers nine Rohto Cooling Eye Drops SKUs sold at retail locations across the United States. Check your bottles carefully — if the UPC, lot code and expiration date match any listing below, do not use the product.

Rohto Cooling Eye Drops ALL-IN-ONE (0.4 fl oz)

UPC: 310742010862
Lot Codes: 3H1V; 3J1V, 3J2V; 3K1V; 4A1V, 4A2V; 4B1V, 4B2V; 4G1V, 4G2V, 4G3V; 4I1V, 4I2V, 4I2VA; 4J1V, 4J2V; 4K2V, 4K3V, 4K4V; 5B1V, 5B2V, 5B3V; 5D1V; 5E1V, 5E2V, 5E3V; 5H1V; 5I1V; 5J1V, 5J2V; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V; 6A1V, 6A2V; 6B1V; 6C1V
Expiration Dates: 2026/07; 2026/09; 2026/10; 2026/12; 2027/01; 2027/06; 2027/08; 2027/09; 2027/10; 2028/01; 2028/03; 2028/04; 2028/07; 2028/08; 2028/09; 2028/11; 2028/12; 2029/01; 2029/02

Rohto Cooling Eye Drops Max Strength (0.4 fl oz)

UPC: 310742011012
Lot Codes: 3H2V, 3H3V; 3J1V, 3J3V, 3J4V, 3J5V; 3K1V, 3K2V; 4A2V; 4B1V, 4B2V, 4B3V; 4F1V, 4F2V, 4F3V, 4F4V; 4G2V, 4G3V, 4G4V, 4G5V; 4H1V; 4I1V, 4I2V, 4I4V, 4I5V
Expiration Dates: 2026/07; 2026/09; 2026/10; 2026/12; 2027/01; 2027/05; 2027/06; 2027/07; 2027/08

Rohto Cooling Eye Drops Max Strength Twin Pack

UPC: 310742011210
Lot Codes: 3H1V; 3J2V; 4A1V, 4A1VA; 4G1V; 4I3V; 5A1V; 5B3V; 5G3V; 5J1V; 5L1V; 6A1V; 6B4V; 6C2V
Expiration Dates: 2026/07; 2026/09; 2026/12; 2027/06; 2027/08; 2027/12; 2028/01; 2028/06; 2028/09; 2028/11; 2028/12; 2029/01; 2029/02

Rohto Cooling Eye Drops Optic Glow (0.4 fl oz)

UPC: 310742010916
Lot Codes: 3H1V, 3H1VA; 3J1V, 3J2V; 3K1V; 4F1V, 4F1VA; 4H1V; 4I1V; 4K1V, 4K2V; 5A1V, 5A2V; 5D1V; 5E1V; 5J1V, 5J2V; 6B1V; 6C1V, 6C1VA, 6C1VB
Expiration Dates: 2025/07; 2025/09; 2025/10; 2027/05; 2027/07; 2027/08; 2027/10; 2027/12; 2028/03; 2028/04; 2028/09; 2029/01; 2029/02

Rohto Cooling Eye Drops Digi Eye (0.4 fl oz)

UPC: 310742010602
Lot Codes: 4B1V, 4B1VA; 4J1V
Expiration Dates: 2027/01; 2027/09

Rohto Cooling Eye Drops Dry Aid (0.34 fl oz)

UPC: 310742011135
Lot Codes: 4G1VA; 4J1VA; 5A1V; 5D1VA; 5G1VA; 5I2V, 5I2VB; 5L2VA
Expiration Dates: 2027/06; 2027/09; 2027/12; 2028/03; 2028/06; 2028/08; 2028/11

Rohto Cooling Eye Drops Dry Aid Twin Pack

UPC: 310742011159
Lot Codes: 4G1V; 4J1V; 5D1V; 5G1V; 5I2V, 5I2VB
Expiration Dates: 2027/06; 2027/09; 2028/03; 2028/06; 2028/08

Rohto Cooling Eye Drops Cool Relief (0.4 fl oz)

UPC: 310742010749
Lot Codes: 3J1V; 4A1V; 4G1V, 4G2V; 4I1V; 4J1V; 5A1V; 5B1V; 5F1V, 5F1VA; 5H1V, 5H1VA; 5J1V, 5J1VA; 5L1V; 6B1V
Expiration Dates: 2026/09; 2026/12; 2027/06; 2027/08; 2027/09; 2027/12; 2028/01; 2028/05; 2028/07; 2028/09; 2028/11; 2029/01

What You Should Do

Do not use any Rohto Cooling eye drops that match the UPC, lot code and expiration dates above. Consumers should either return the product to the place of purchase for a refund or dispose of it safely to avoid potential health risks.

If you have used an affected product and are experiencing redness, pain, vision changes, discharge, or other eye symptoms, seek immediate medical attention. Keep the product bottle (if available) and provide lot and UPC information to your healthcare provider.

For questions about the recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or consult the FDA’s recall notice on its website for updates.

Recall Classification: Class II — products may cause temporary or reversible adverse health consequences.