Nearly 12 Million Eye Drop Bottles RECALLED Due To Potential Contamination

The Food and Drug Administration announced this week that a large batch of a popular medicated eye drop brand had been recalled.

According to reports, the nearly 12 million bottles of Rohto medication were impacted due to “lack of assurance of sterility.”

Per Fox Business: 

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.

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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.

As in the case of other recent food and drug recalls, the news sparked some discussion on social media:

Again!!!! Made where

— Marisa (@marisaciao) July 31, 2026

Couldn’t find any Rohtos on shelves to save my life and a Google search said there’s been a recall. I’m shook

— Vincenzo (@HeHateV) July 30, 2026

it's safer to just cry you eyes out cutting an onion at this point

— Jiaoying Summers (@JiaoyingSummers) July 30, 2026

USA Today added these details:

Eight different types of Rohto eye drops are subject to the recall. The medication was sold over-the-counter nationwide, according to the FDA.

Consumers should not use recalled eye drops, as they could be contaminated or cause infection. While the FDA did not specify in the enforcement report, recalled products can often be returned to the place of purchase; call your local store to check your options.

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The development comes on the heels of a similar recall earlier this year: