Rohto Optic Glow Liquid
FDA Recall NDC 10742-8160

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Rohto Optic Glow (NDC 10742-8160). A significant event, classified as Class II, was initiated on Jul 14, 2026 by The Mentholatum Company. The reported reason for this action was: "Lack of Assurance of Sterility"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0718-2026ONGOING

July 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0718-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jul 14, 2026
Reported
Jul 29, 2026
Quantity
1,278,457 cartons

Recall Profile & Regulatory Data

Event ID
99440
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rohto-Mentholatum (Vietnam) Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Batch or Lot Expiration Information
Lot# : 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.
Affected Packages Involved in this Recall
10742-8160-1Product
3107420109Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.