Rohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.
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 recall is for a lack of sterility in an ophthalmic (eye) product, which presents a high risk of harm to users.
Plain-English summary
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80) due to a lack of assurance of sterility.
This recall affects multiple lots of the 0.4 FL OZ (13 mL) ophthalmic solution distributed nationwide within the United States. Affected products include various lot numbers with expiration dates ranging from September 2026 through January 2029.
Consumers should stop using the affected eye drops immediately and contact the distributor or retailer for information regarding returns or replacements.
The recalled product
- Product
- ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
- Brand
- ROHTO
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Category
- Drug — Ophthalmic Solutions
- Hazard
- Affected units
- 2,910,148
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 #: 3J1V
- Exp. Date 2026/09
- 4A1V
- Exp. Date 2026/12
- 4G1V
- 4G2V
- Exp. Date 2027/06
- 4I1V
- Exp. Date 2027/08
- 4JIV
- Exp. Date 2027/09
- 5A1V
- Exp. Date 2027/12
- 5B1V
- Exp. Date 2028/01
- 5F1V
- Exp. Date 2028/05
- 5F1VA
- 5H1V & 5H1VA
- Exp. Date 2028/07
UPCs (2)
- 0310742010749
- 310742010749
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
Same manufacturer · Rohto-Mentholatum (Vietnam) Co., Ltd.
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