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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- Affected units
- 1,278,457
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Rohto-Mentholatum (Vietnam) Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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