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
USRohto 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
Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Ho Chi Minh |
| State | N/A |
| Openfda › Upc › 1 | 0310742010916 |
| Openfda › Upc › 2 | 310742010916 |
| Openfda › Unii › 1 | MZ1131787D |
| Openfda › Unii › 2 | FZ989GH94E |
| Openfda › Unii › 3 | 6DC9Q167V3 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 2531299 |
| Openfda › Spl id | 5363276c-3a05-d0bc-e063-6394a90ab94e |
| Openfda › Brand name | ROHTO OPTIC GLOW |
| Openfda › Spl set id | df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff |
| Openfda › Package ndc › 1 | 10742-8160-1 |
| Openfda › Package ndc › 2 | 3107420109 |
| Openfda › Product ndc | 10742-8160 |
| Openfda › Generic name | NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | NAPHAZOLINE HYDROCHLORIDE |
| Openfda › Substance name › 2 | POVIDONE, UNSPECIFIED |
| Openfda › Substance name › 3 | PROPYLENE GLYCOL |
| Openfda › Manufacturer name | The Mentholatum Company |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 99440 |
| Address 1 | No. 16 Vsip, Street No. 5 |
| Address 2 | Vietnam Singapore Industrial Park |
| Code info | 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. |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 1,278,457 cartons |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260714 |
| Initial firm notification | Letter |
| Center classification date | 20260723 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmRohto-Mentholatum (Vietnam) Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Rohto-Mentholatum (Vietnam) Co., Ltd. - 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 Check if your household is affected: https://therecallfile.com/recalls/rohto-cooling-eye-drops-optic-glow-naphazoline-hydrochloride-0-03-povi/FDA-D-0718-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKMHRA Safety Roundup: August 2026
MHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users...
AustraliaCAROTONE skin-brightening products found to contain undeclared prescription-only medicine
CAROTONE skin-brightening products found to contain undeclared prescription-only medicine
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....
UKClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....