FDAHealthJuly 14, 2026
Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Or
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 14, 2026
Nationwide within the United States
What's affected?
- Product
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
- Brand
- ROHTO DRY-AID
- UPC
- 310742011159
- Lot code
- 4G1V
Additional details
Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 353 cartons.
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