The Recall Desk
SevereFDA (Drugs)·D-0715-2026·Announced 2026-07-29

ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a sterile ophthalmic drug product where sterility cannot be assured, posing a risk of serious eye infection. Per the rubric, FDA Class II recalls with potential for serious health consequences are classified as Severe (score 4).

Plain-English summary

Rohto-Mentholatum (Vietnam) Co., Ltd. is voluntarily recalling ROHTO Cooling Eye Drops ALL-IN-ONE, a sterile ophthalmic product, due to a lack of assurance of sterility. The product is packaged as 0.4 FL OZ (13 mL) cartons and distributed by The Mentholatum Company, Orchard Park, NY 14127.

The recall includes 1,033,266 cartons across numerous lots with expiration dates ranging from July 2026 through February 2029. Affected lot numbers include 3H1V, 3J1V, 3J2V, 3K1V, 4A1V, 4A2V, 4B1V, 4B2V, 4G1V, 4G2V, 4G3V, 4I1V, 4I2V, 4I2VA, 4J1V, 4J2V, 4K2V, 4K3V, 4K4V, 5B1V, 5B2V, 5B3V, 5D1V, 5E1V, 5E2V, 5E3V, 5H1V, 5I1V, 5J1V, 5J2V, 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V, 6A1V, 6A2V, 6B1V, and 6C1V.

The recalled product was distributed nationwide within the United States. Consumers who have the recalled eye drops should stop using the product and return it to the place of purchase for a full refund. Healthcare providers should also be aware of this recall when evaluating patients who may have used the affected product.

This recall was initiated as a result of a routine FDA inspection that identified a lack of assurance of sterility. The Mentholatum Company is notifying distributors and retailers of the recall and is working with the FDA to ensure the affected product is removed from the market.

The recalled product

Product
ROHTO (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE)
Brand
ROHTO
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Ophthalmic / Eye Drops
Hazard
  • sterility
  • eye-infection
  • contamination

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. Date 2026/07
  • 3J1V
  • 3J2V
  • Exp. Date 2026/09
  • 3K1V
  • Exp. Date 2026/10
  • 4A1V
  • 4A2V
  • Exp. Date 2026/12
  • 4B1V
  • 4B2V
  • Exp. Date 2027/01
  • 4G1V
  • 4G2V
  • 4G3V
  • Exp. Date 2027/06
  • 4I1V
  • 4I2V
  • 4I2VA Exp. Date 2027/08

UPCs (2)

  • 0310742010862
  • 310742010862

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ROHTO

Same category