The Recall Desk
HighFDA (Drugs)·D-0721-2026·Announced 2026-07-29

ROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns

The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.

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: FDA Class II recall for eye drops with lack of assurance of sterility. No reported illnesses or injuries, but sterility failure in ophthalmic products poses a risk-of-harm where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration is recalling ROHTO DRY-AID Cooling Eye Drops (povidone 0.68%, propylene glycol 0.3%). The recall is being conducted by Rohto-Mentholatum (Vietnam) Co., Ltd. and distributed by The Mentholatum Company due to lack of assurance of sterility. A total of 353 cartons were distributed nationwide within the United States. Consumers should stop using the product and return it to the point of purchase for a full refund or contact The Mentholatum Company for assistance.

The recalled product

Product
ROHTO DRY-AID (POVIDONE, PROPYLENE GLYCOL)
Brand
ROHTO DRY-AID
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Over-the-Counter Eye Drops
Hazard
  • sterility-failure
  • ophthalmic
  • 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 (10)

  • Lot #: 4G1V
  • Exp 2027/06
  • 4J1V
  • 512VB 2027/09
  • 5D1V
  • 2028/03
  • 5G1V
  • 512VB 2028/06
  • 512V
  • 512VB 2028/08

UPCs (1)

  • 310742011159

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ROHTO DRY-AID

Same category