FDA Drug recall D-0720-2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Compa…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Compa… by Rohto Mentholatum Vietnam, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0720-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-14 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rohto Mentholatum Vietnam |
| Distribution | US |
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
Identifiers
| upc | 310742011135 |
|---|---|
| ndc | 10742-8162-1 |
| ndc | 10742-8162-2 |
| ndc | 3107420111 |
| code_info | Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA,…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0720-2026%22
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