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

The voluntary recall was issued by Vietnam-based Rohto-Mentholatum and includes eye drops marketed to relieve redness, dryness and eye strain.

According to the FDA, the recall affects 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide.

The FDA said the products were recalled because of a “lack of assurance of sterility,” meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms.

Federal regulators classified the action as a Class II recall, meaning use of the products could cause temporary or medically reversible health effects, but serious adverse health consequences are unlikely.

The recall covers eight Rohto Cooling Eye Drops products — including ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief — in single and twin-pack configurations.

Affected products carry expiration dates ranging from July 2025 through February 2029. Consumers should compare 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.

The eye drops were manufactured by Rohto-Mentholatum in Vietnam and distributed by The Mentholatum Company, based in Orchard Park, New York.

Consumers whose products are included in 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 after the FDA recently classified the recall of more than 2.5 million bottles of a prescription steroid eye medication as a Class II action because of 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.

Last month, the FDA also announced 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.