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.
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 3/5 (High).
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 Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Affected units
- 353
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
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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