The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of nearly 12 million bottles of Rohto Cooling Eye Drops over “lack of assurance of sterility.”
This raises concerns about potential microbial contamination.
The Vietnam-based manufacturer Rohto-Mentholatum voluntarily initiated the recall, stating that 11,960,623 cartons across eight product varieties distributed by The Mentholatum Company have been affected.
Some of these include All-in-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, available in either single or twin pack versions.
As stated by the FDA, all these affected products with an expiry period between July 2025 and February 2029 cannot be ensured to be free from dangerous pathogens. The FDA has placed this move under a Class II recall, which means that use of these eyedrops can lead to non-life-threatening adverse health consequences.
All these measures have come following increased focus on eye products. As reported earlier in the year, Lupin Pharmaceuticals issued a recall order of over 2.5 million units of a prescription steroid eye drug due to foreign material contamination.
Consumers are requested to check the lot numbers and expiration dates on their Rohto packaging against the FDA’s recall list. Affected products should be disposed of immediately or returned to the place of purchase for a full refund.
FDA advises that those experiencing any adverse reactions after using the drops should immediately consult a doctor.
2026-08-01 18:41:00
