Rohto-Mentholatum (Vietnam) Co., Ltd. Rohto Cooling Eye Drops Dry Aid Recall (Not Provided)
The recall is for Rohto Cooling Eye Drops Dry Aid sterile eye drops due to lack of assurance of sterility. It covers 97,201 cartons across multiple lots with expiration dates from 2027/06 to 2028/11. Lot numbers affected include 4G1VA (Exp. 2027/06), 4J1VA (Exp. 2027/09), 5A1V (Exp. 2027/12), 5D1VA (Exp. 2028/03), 5G1VA (Exp. 2028/06), 512V/512VB (Exp. 2028/08), and 5L2VA (Exp. 2028/11).
| Brand | Rohto-Mentholatum (Vietnam) Co., Ltd. |
|---|---|
| Product | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1 |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 6076306 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the affected Rohto Cooling Eye Drops Dry Aid immediately.
- Check your product label for the listed Lot numbers and Expiration Dates; discard any that match.
- Contact The Mentholatum Company for guidance on disposal, refunds, or replacements.
How to identify the recalled item
| Lot / date codes | Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11. |
|---|---|
| Lot / date codes | Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.