FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Dry Aid recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops recalled for sterility concern
Rohto Cooling Eye Drops Dry Aid may not meet sterility standards required for eye medications. The affected product was distributed nationwide. No injuries have been reported.
- Check if you have Rohto Cooling Eye Drops Dry Aid with lot numbers 4G1VA, 4J1VA, 5A1V, 5D1VA, 5G1VA, 512V, 512VB, or 5L2VA (expiration dates range from June 2027 to November 2028).
- Stop using the product if you have a recalled lot.
- Contact Rohto-Mentholatum or your pharmacy for instructions on return or disposal.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
97201 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0720-2026More Rohto-Mentholatum (Vietnam) Co., Ltd. recalls
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Cool Relief recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Digi Eye recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Optic Glow recalled for lack of sterility assurance
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