The Recall Desk
SevereFDA (Drugs)·D-0718-2026·Announced 2026-07-29

FDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns

The FDA is recalling ROHTO OPTIC GLOW sterile eye drops due to a lack of assurance of sterility. The recall affects 1,278,457 cartons 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. Per the rubric, FDA Class II recalls with reported hospitalization or significant injury are scored as Severe (4). The lack of sterility assurance for sterile eye drops poses a risk of serious infection, which is a significant health hazard.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling ROHTO OPTIC GLOW (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%) sterile eye drops, 0.4 FL OZ (13 mL), due to a lack of assurance of sterility. The product was manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. and distributed by The Mentholatum Company, Orchard Park, NY.

The recall includes 1,278,457 cartons distributed nationwide within the United States. The affected lots are identified by the following lot numbers and expiration dates: 3H1V, 3H1VA (Exp. 2025/07); 3J1V, 3J2V (Exp. 2025/09); 3K1V (Exp. 2025/10); 4F1V, 4F1VA (Exp. 2027/05); 4H1V (Exp. 2027/07); 4I1V (Exp. 2027/08); 4K1V, 4K2V (Exp. 2027/10); 5A1V, 5A2V (Exp. 2027/12); 5D1V (Exp. 2028/03); 5E1V (Exp. 2028/04); 5J1V, 5J2V (Exp. 2028/09); 6B1V (Exp. 2029/01); 6C1V, 6C1VA, 6C1VB (Exp. 2029/02).

Consumers who have the recalled product should stop using it immediately and return it to the place of purchase for a full refund. Healthcare providers should not use the product for intraocular procedures. For questions, consumers may contact The Mentholatum Company.

This is a Class II recall, meaning use of or exposure to the product may cause temporary adverse health consequences.

The recalled product

Product
ROHTO OPTIC GLOW (NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL)
Brand
ROHTO OPTIC GLOW
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Ophthalmic / Eye Drops
Hazard
  • sterility
  • 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 (20)

  • Lot #: 3H1V
  • 3H1VA
  • Exp. Date 2025/07
  • 3J1V
  • 3J2V
  • Exp. Date 2025/09
  • 3K1V
  • Exp. Date 2025/10
  • 4F1V
  • Exp. Date 2027/05
  • 4F1VA
  • 4H1V
  • Exp. Date 2027/07
  • 4I1V
  • Exp. Date 2027/08
  • 4K1V
  • 4K2V
  • Exp. Date 2027/10
  • 5A1V
  • 5A2V

UPCs (2)

  • 0310742010916
  • 310742010916

Distribution

Distributed nationwide across the United States.

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