The Recall Desk
HighFDA (Drugs)·D-0717-2026·Announced 2026-07-29

ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a sterile ophthalmic product where lack of sterility assurance poses a risk of microbial contamination and potential eye infection. No illnesses or injuries have been reported, which aligns with the High severity threshold for risk-of-harm products without reported injury.

Plain-English summary

Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%) due to lack of assurance of sterility. The product is packaged as a sterile ophthalmic solution in a twin pack of 0.4 FL OZ (13 mL) bottles, with UPC 310742011210 and NDC 10742-8158-2.

The recall includes multiple lot numbers with various expiration dates ranging from July 2026 through December 2029. The affected lots are: 3H1V, 3J2V, 4A1V, 4A1VA, 4G1V, 4I3V, 5A1V, 5B3V, 5G3V, 5J1V, 5L1V, 6A1V, 6B4V, and 6C2V.

A total of 499,673 cartons were distributed nationwide within the United States. The product was manufactured in Vietnam and distributed by The Mentholatum Company, located in Orchard Park, NY 14127.

Consumers who have the recalled product should stop using it immediately and return it to the place of purchase for a full refund. For questions, consumers should contact the company directly.

The recalled product

Product
ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
Brand
ROHTO
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Ophthalmic / Eye Drops
Hazard
  • sterility
  • microbial-contamination
  • eye-infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 3H1V
  • Exp. Date2026/07
  • 3J2V
  • Exp. Date 2026/09
  • 4A1V
  • 4A1VA
  • Exp. Date 2026/12
  • 4G1V
  • Exp. Date 2027/06
  • 4I3V
  • Exp. Date 2027/08
  • 5A1V
  • Exp. Date 2027/12
  • 5B3V
  • Exp. Date2028/01
  • 5G3V
  • Exp. Date 2028/06
  • 5J1V
  • Exp. Date 2028/09
  • 5L1V

UPCs (2)

  • 0310742011012
  • 310742011210

Distribution

Distributed nationwide across the United States.

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