The voluntary recall was issued by Vietnam-based Rohto-Mentholatum and affects eye drops marketed to relieve redness, dryness and eye strain. According to the FDA, a total of 11,960,623 cartons distributed nationwide are included in the recall.
The recall adds to a series of recent FDA enforcement actions involving ophthalmic products and other medications. Consumers are being urged to verify whether their eye drops are part of the affected lots by checking the manufacturer’s recall notice or the FDA’s website.
FDA Cites Sterility Concerns Affecting Nearly 12 Million Cartons
According to the FDA, the recalled products were removed from the market because of a “lack of assurance of sterility,” meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms.
The recall covers 11,960,623 cartons of Rohto Cooling Eye Drops that were distributed across the United States. Federal regulators classified the action as a Class II recall, a designation used when exposure to a product may cause temporary or medically reversible health effects, while the probability of serious adverse health consequences is considered low.
Eight Rohto Eye Drop Products Are Included
The recall applies to eight Rohto Cooling Eye Drops products sold in both single and twin-pack configurations. The affected products include ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief.
Affected products carry expiration dates ranging from July 2025 through February 2029. According to the FDA, consumers should compare both the lot number and expiration date on their packaging with the manufacturer’s recall notice or the FDA’s website to determine whether their product is included in the recall.
Recall Follows Other Recent FDA Enforcement Actions
The Rohto recall comes shortly after the FDA classified another Class II recall involving ophthalmic medication. According to the agency, more than 2.5 million bottles of prescription prednisolone acetate ophthalmic suspension USP, 1% were voluntarily recalled by Lupin Pharmaceuticals Inc. after a foreign substance was identified in certain lots.
The FDA enforcement report states that the Lupin recall affects 2,530,182 bottles of the steroid eye medication.
Last month, the FDA also announced the recall of certain lots of generic cetirizine hydrochloride tablets, commonly sold as generic versions of Zyrtec. According to Fox Business, the products were recalled because of concerns that they may have been cross-contaminated with another medication capable of triggering potentially life-threatening reactions.
