Rohto recalls cooling eye drops made in Vietnam due to lack of sterility assurance. Products with specific lot numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
Rohto is recalling cooling eye drops that may not be sterile. This could lead to infections if used improperly. The recall affects specific batches made in Vietnam with certain lot numbers and expiration dates.
The eye drops lack assurance of sterility, meaning they might not be clean enough to use safely. If contaminated, they could cause infections or other health issues when applied to the eyes.
People who own or use the recalled Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%) with lot numbers 4B1V, 4B1VA, or 4J1V are affected. Those with the product's expiration date in 2027 are at risk.
Check the product label for the lot numbers 4B1V, 4B1VA, or 4J1V. The expiration date for these products is either January 2027 or September 2027. The product was made in Vietnam and distributed by The Mentholatum Company.
Look for the lot numbers 4B1V, 4B1VA, or 4J1V on the packaging.
Rohto is recalling cooling eye drops that may not be sterile due to lack of assurance of sterility.
Products with lot numbers 4B1V, 4B1VA, or 4J1V and expiration dates in January or September 2027.
Check the product label for the lot numbers 4B1V, 4B1VA, or 4J1V and the expiration date.
We’ve drafted a message you can send Rohto to request your refund or repair — edit it as you like.
Subject: Recall D-0719-2026 — Rohto Rohto Hello, I own a Rohto that is covered by recall D-0719-2026 from Rohto. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
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