Rohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.
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: The product is an ophthalmic drug (eye drops) and the hazard is a lack of sterility, which poses a high risk of infection or harm to the user.
Plain-English summary
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), distributed by The Mentholatum Company.
The recall is being conducted due to a lack of assurance of sterility in the product.
This recall affects specific lots of the product distributed nationwide within the United States. Consumers should check their product's lot number and expiration date to see if it matches the affected batches.
The recalled product
- Product
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 6,076,306
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 #: 3H2V
- 3H3V
- Exp. Date 2026/07
- 3J1V
- 3J3V
- 3J4V
- 3J5V
- Exp. Date 2026/09
- 3K1V
- 3K2V
- Exp. Date 2026/10
- 4A2V
- Exp. Date 2026/12
- 4B1V
- 4B2V
- 4B3V
- Exp. Date 2027/01
- 4F1V
- 4F2V
- 4F3V
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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