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Nearly 12M Bottles Of Popular Eye Drops Recalled: What To Know In MI

The FDA issued a Class II voluntary recall for the eyedrops, which were distributed and sold nationwide.

Nearly 12 million bottles of eye drops sold nationwide, including in Michigan, have been recalled because the products may be unsterile, according to the Food and Drug Administration.

In a notice posted on the FDA's website, officials said Vietnam-based Rohto-Mentholatum Co. issued a voluntary recall for 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide.

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According to the FDA, the eye drops were recalled after the manufacturer could not ensure the products were sterile and free of potentially harmful microorganisms.

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

Affected products also bear expiration dates ranging from July 2025 through February 2029.

See a full list of affected products, including lot numbers and expiration dates.

The recalled products are marketed to relieve a range of common eye symptoms, including dryness, redness, irritation, eye strain, burning and discomfort, with some formulations also designed to brighten or "whiten" the eyes.

As of Saturday, the recall was a Class II, which means it involves products that may cause temporary or medically reversible health problems. There is a low risk of serious injury.

Consumers who purchased the recalled eye drops should stop using them immediately and either discard them or return them to the retailer for a full refund.

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