ROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
Rohto Digi-Eye cooling eye drops are recalled due to a lack of assurance of sterility. The recall affects 65,219 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 involving a sterility assurance failure for a sterile ophthalmic product. Per the rubric, FDA Class II recalls with potential for serious health consequences fall under the Severe category (score 4).
Plain-English summary
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO DIGI-EYE (hypromellose 0.35%, tetrahydrozoline HCl 0.05%) sterile ophthalmic solution, 0.4 FL OZ (13 mL) cartons. The product is being recalled because of a lack of assurance of sterility, meaning the manufacturer cannot guarantee the product meets sterility requirements for use in or near the eye.
The recall includes 65,219 cartons distributed nationwide within the United States. The affected units are identified by lot numbers 4B1V, 4B1VA (expiration date 2027/01) and 4J1V (expiration date 2027/09).
Consumers who have the recalled eye drops should stop using them and return them 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 product.
The recall was classified as FDA Class II, indicating a temporary or medically reversible adverse health consequence, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- ROHTO DIGI-EYE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE)
- Brand
- ROHTO DIGI-EYE
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 65,219
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 (5)
- Lot #: 4B1V
- 4B1VA
- Exp. Date 2027/01
- 4J1V
- Exp. Date 2027/09
UPCs (1)
- 310742010602
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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