Rohto Cooling Eye Drops Cool Relief recall: Sterility Concern
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Why was Rohto Cooling Eye Drops Cool Relief recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.
- Product
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Quantity
- 2910148 cartons
- Distribution
- Nationwide within the United States
- Recall date
- July 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)