FDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.
What this means for you
Illness, injury, or structural failure has been reported. 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 sterile ophthalmic products with a lack of assurance of sterility, which poses a risk of serious infection or injury if used. Per the rubric, FDA Class II recalls with potential for significant harm are scored as Severe (4).
Plain-English summary
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO DRY-AID (povidone 0.68%, propylene glycol 0.3%) sterile ophthalmic solution, packaged in 0.34 FL OZ (10 mL) bottles. The product is distributed by The Mentholatum Company, Orchard Park, NY, and was manufactured in Vietnam.
The recall is being issued due to a lack of assurance of sterility. The affected lots are identified by the following lot numbers and expiration dates: 4G1VA (Exp. 2027/06), 4J1VA (Exp. 2027/09), 5A1V (Exp. 2027/12), 5D1VA (Exp. 2028/03), 5G1VA (Exp. 2028/06), 512V (Exp. 2028/08), 512VB (Exp. 2028/08), 5L2VA (Exp. 2028/11), and 512VB (Exp. 2028/11).
A total of 972,001 cartons of the product are included in the recall. The product was distributed nationwide within the United States.
Consumers who have the recalled product should stop using it immediately and return it to the place of purchase for a full refund. Consumers with questions may contact the company for additional information. The recall is being conducted as a Class II recall by the U.S. Food and Drug Administration.
The recalled product
- Product
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Affected units
- 97,201
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 (14)
- Lot #: 4G1VA
- Exp. Date 2027/06
- 4J1VA
- Exp. Date 2027/09
- 5A1V
- Exp. Date 2027/12
- 5D1VA
- Exp. Date 2028/03
- 5G1VA
- Exp. Date 2028/06
- 512V
- 512VB Exp. Date 2028/08
- 5L2VA
- 512VB 2028/11.
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.
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