The US Food and Drug Administration (FDA) announced a Class II recall for 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide. Vietnam-based Rohto-Mentholatum (Vietnam) Co., Ltd. voluntarily initiated the ongoing recall due to a lack of assurance of sterility. The recall was initiated on July 14 and classified as Class II by the FDA on July 23.

The products affected by the recall include the following 8 Rohto Cooling Eye Drops products:

• All-In-One, Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL)

• Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, Twin Pack, 0.4 FL OZ (13 mL)

• Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL)

• Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)

• Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL)

• Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, Twin Pack 0.34 FL OZ (10 mL)

• Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)

The recalled products have expiration dates ranging from July 2025 through February 2029. The complete list of affected lot numbers and expiration dates is available in the FDA recall notice.

According to the FDA, a Class II recall is issued when use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled products are marketed to relieve redness, dryness, eye strain, and other common eye symptoms. Rohto Optic Glow is also marketed as an eye-whitening product.