Nearly 12 million bottles of Rohto eye drops have been recalled over concerns that the products may not be sterile, according to a Food and Drug Administration (FDA) enforcement report.

The voluntary recall was initiated by Rohto-Mentholatum, based in Vietnam, and covers eye drops marketed to relieve redness, dryness, and eye strain. According to the FDA, the action affects 11,960,623 cartons of Rohto Cooling Eye Drops that were distributed nationwide.

The agency stated that the products were recalled due to a "lack of assurance of sterility," meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms. Sterility is a particularly critical requirement for ophthalmic products because they are applied directly to the surface of the eye, where microbial contamination can lead to serious infections.

Federal regulators classified the action as a Class II recall, indicating that use of the affected products could cause temporary or medically reversible health effects, though serious adverse health consequences are considered unlikely. Under the FDA's three-tier recall system, Class II sits between Class I, which involves a reasonable probability of serious harm or death, and Class III, where exposure is unlikely to cause adverse health consequences.

The recall encompasses eight Rohto Cooling Eye Drops products — including ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief — available in both single and twin-pack configurations. Affected products carry expiration dates ranging from July 2025 through February 2029. Consumers are advised to compare the lot number and expiration date on their packaging against the manufacturer's recall notice or the FDA's website to determine whether their product is included.

The eye drops were manufactured by Rohto-Mentholatum in Vietnam and distributed by The Mentholatum Company, headquartered in Orchard Park, New York. Consumers who possess products covered by the recall should stop using them immediately and either dispose of them or return them to the place of purchase for a full refund.

The recall comes amid heightened scrutiny of over-the-counter ophthalmic products. In 2023, a multistate outbreak of drug-resistant bacterial infections linked to contaminated EzriCare Artificial Tears resulted in multiple vision losses and at least one death, prompting increased oversight of eye drop manufacturing and distribution.

The announcement follows a separate FDA action in which the agency classified the recall of more than 2.5 million bottles of a prescription steroid eye medication as a Class II recall due to concerns about foreign material found in certain lots. Lupin Pharmaceuticals Inc. voluntarily recalled 2,530,182 bottles of prednisolone acetate ophthalmic suspension USP, 1%, after the presence of a foreign substance was identified, according to an FDA enforcement report.

Additionally, the FDA announced last month the recall of certain lots of generic cetirizine hydrochloride tablets, commonly sold as generic versions of Zyrtec, over concerns they may have been cross-contaminated with another medication that could trigger potentially life-threatening reactions.

FOX Business' Brittany Miller and Bonny Chu contributed to this report.

Source: Fox Business