Rohto Liquid
FDA Recall NDC 10742-8158

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

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Rohto (NDC 10742-8158). 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-0716-2026ONGOINGD-0717-2026ONGOING

July 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0716-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jul 14, 2026
Reported
Jul 29, 2026
Quantity
6076306 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 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
Batch or Lot Expiration Information
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, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.
Affected Packages Involved in this Recall
10742-8158-1Product
10742-8158-2Product
3107420110Product

July 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0717-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jul 14, 2026
Reported
Jul 29, 2026
Quantity
499,673 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 Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Batch or Lot Expiration Information
Lot# : 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Affected Packages Involved in this Recall
10742-8158-1Product
10742-8158-2Product
3107420112Product

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.