Rohto Cooling Eye Drops Max Strength — Class II drug recall D-0716-2026
Ongoing recall by Rohto-Mentholatum (Vietnam) Co., Ltd., reported 2026-07-29, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0716-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A, Vietnam |
| Recall initiated | 2026-07-14 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 6,076,306 cartons |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00310742011012 |
| NDC | 10742-8158, 10742-8158-01, 10742-8158-02 |
| Lot numbers | 2026/07, 2026/09, 2026/10, 2026/12, 2027/01, 2027/05, 2027/06, 2027/07, 2027/08, 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 |
Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0716-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.