drugs MODERATE Updated 2026-07-29

Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrah

See all recalls from Rohto-Mentholatum (Vietnam) Co., Ltd. →

Recalled Product

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

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Hazard / Issue

Lack of Assurance of Sterility

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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