The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of nearly 12 million cartons of Rohto Cooling Eye Drops due to concerns over product sterility. The recall affects multiple over-the-counter eye drop products sold across the United States and has prompted consumers to immediately check their medicine cabinets. The FDA classified the action as a Class II recall, meaning the products may cause temporary or medically reversible health effects if used.
The recall was initiated after the manufacturer, Rohto-Mentholatum (Vietnam) Co., Ltd., reported a “lack of assurance of sterility” during the production process. Since eye drops are applied directly to the eyes, maintaining sterility is essential to prevent bacterial contamination and possible eye infections. Even if contamination has not been confirmed, products that cannot be guaranteed sterile pose a potential health risk.
According to the FDA, 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide by The Mentholatum Company are included in the recall. The affected products include several popular variants such as:
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL)
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL)
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL)
- Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL)
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL)
Consumers should check the UPC numbers, lot numbers, and expiration dates listed on the FDA recall notice to determine whether their eye drops are affected.
The FDA designated the recall as a Class II Recall, indicating that exposure to the recalled products could result in temporary or medically reversible adverse health effects, while the risk of serious injury is considered relatively low. However, because eye drops bypass many of the body’s natural defenses, contaminated products can increase the risk of eye irritation, infection, inflammation, redness, blurred vision, and, in rare cases, more serious complications if left untreated.
Health officials are urging consumers to stop using the recalled eye drops immediately. Anyone who owns one of the affected products should either safely dispose of it or return it to the retailer for a refund. Individuals who experience eye pain, swelling, persistent redness, blurred vision, or other unusual symptoms after using the recalled eye drops should seek medical attention promptly and report the incident through the FDA’s MedWatch program.
This latest FDA recall highlights the growing importance of product quality and manufacturing standards for over-the-counter medications. Eye drops must be produced under strict sterile conditions because any contamination can directly affect eye health. While no widespread injuries linked to this recall have been reported, the FDA advises consumers not to take unnecessary risks and to discontinue use of any affected products.
Consumers are encouraged to review the FDA’s official recall information for the complete list of affected products and lot numbers before continuing to use any Rohto Cooling Eye Drops. As investigations continue, health officials will monitor the situation and provide updates if additional products become affected.
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