The Recall Desk
SevereFDA (Drugs)·D-0720-2026·Announced 2026-07-29

FDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap

Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.

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 sterile ophthalmic products with a lack of assurance of sterility, which poses a risk of serious infection or injury if used. Per the rubric, FDA Class II recalls with potential for significant harm are scored as Severe (4).

Plain-English summary

Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO DRY-AID (povidone 0.68%, propylene glycol 0.3%) sterile ophthalmic solution, packaged in 0.34 FL OZ (10 mL) bottles. The product is distributed by The Mentholatum Company, Orchard Park, NY, and was manufactured in Vietnam.

The recall is being issued due to a lack of assurance of sterility. The affected lots are identified by the following lot numbers and expiration dates: 4G1VA (Exp. 2027/06), 4J1VA (Exp. 2027/09), 5A1V (Exp. 2027/12), 5D1VA (Exp. 2028/03), 5G1VA (Exp. 2028/06), 512V (Exp. 2028/08), 512VB (Exp. 2028/08), 5L2VA (Exp. 2028/11), and 512VB (Exp. 2028/11).

A total of 972,001 cartons of the product are included in the recall. The product was distributed nationwide within the United States.

Consumers who have the recalled product should stop using it immediately and return it to the place of purchase for a full refund. Consumers with questions may contact the company for additional information. The recall is being conducted as a Class II recall by the U.S. Food and Drug Administration.

The recalled product

Product
ROHTO DRY-AID (POVIDONE, PROPYLENE GLYCOL)
Brand
ROHTO DRY-AID
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Ophthalmic / Sterile Eye Drops
Hazard
  • sterility-risk
  • infection-risk

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 (14)

  • Lot #: 4G1VA
  • Exp. Date 2027/06
  • 4J1VA
  • Exp. Date 2027/09
  • 5A1V
  • Exp. Date 2027/12
  • 5D1VA
  • Exp. Date 2028/03
  • 5G1VA
  • Exp. Date 2028/06
  • 512V
  • 512VB Exp. Date 2028/08
  • 5L2VA
  • 512VB 2028/11.

UPCs (1)

  • 310742011135

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ROHTO DRY-AID

Same category