Elevated site urgencyFDA Class II

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0

Lack of Assurance of Sterility

Agency: FDA Drug
Recall date: Jul 14, 2026
Status: Ongoing
Company: Rohto-Mentholatum (Vietnam) Co., Ltd.

1. What product was recalled?

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1

Quantity: 1.033,266 cartons

Code or lot text: Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.

LOT: 3J1V
LOT: 3J2V
LOT: 3K1V
LOT: 4A1V
LOT: 4A2V
LOT: 4B1V
LOT: 4B2V
LOT: 4G1V
LOT: 4G2V
LOT: 4G3V
LOT: 4I1V
LOT: 4I2V
LOT: 4I2VA Exp. Date 2027/08
LOT: 4J1V
LOT: 4J2V
LOT: 4K2V
LOT: 4K3V
LOT: 4K4V Exp. Date2027/10
LOT: 5B1V
LOT: 5B2V
LOT: 5B3V
LOT: 5D1V
LOT: 5E1V
LOT: 5E2V
LOT: 5E3V
LOT: 5H1V
LOT: 5I1V
LOT: 5J1V
LOT: 5J2V
LOT: 5L1V
LOT: 5L1VA
LOT: 5L1VB
LOT: 5L1VC
LOT: 5L1VD
LOT: 5L2V
LOT: 6A1V
LOT: 6A2V
LOT: 6B1V
LOT: Exp. Date 2026/07
LOT: Exp. Date 2026/09
LOT: Exp. Date 2026/10
LOT: Exp. Date 2026/12
LOT: Exp. Date 2027/01
LOT: Exp. Date 2027/06
LOT: Exp. Date 2027/09
LOT: Exp. Date 2028/01
LOT: Exp. Date 2028/03
LOT: Exp. Date 2028/04
LOT: Exp. Date 2028/07
LOT: Exp. Date 2028/08
LOT: Exp. Date 2028/09
LOT: Exp. Date 2028/11
LOT: Exp. Date 2028/12
LOT: Exp. Date 2029/01 & Lot 6C1V
LOT: Exp. Date 2029/02.
LOT: Lot #: 3H1V
NDC: 10742-8146
NDC: 10742-8146-1
NDC: 3107420108
RECALL-NUMBER: D-0715-2026
UPC: 0310742010862
UPC: 310742010862

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

Quantity: 2910148 cartons

Code or lot text: 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, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.

LOT: 4A1V
LOT: 4G1V
LOT: 4G2V
LOT: 4I1V
LOT: 4JIV
LOT: 5A1V
LOT: 5B1V
LOT: 5F1V
LOT: 5F1VA
LOT: 5H1V & 5H1VA
LOT: 5J1V
LOT: 5J1VA
LOT: 5L1V
LOT: 6B1V
LOT: Exp. Date 2026/09
LOT: Exp. Date 2026/12
LOT: Exp. Date 2027/06
LOT: Exp. Date 2027/08
LOT: Exp. Date 2027/09
LOT: Exp. Date 2027/12
LOT: Exp. Date 2028/01
LOT: Exp. Date 2028/05
LOT: Exp. Date 2028/07
LOT: Exp. Date 2028/09
LOT: Exp. Date 2028/11
LOT: Exp. Date 2029/01.
LOT: Lot #: 3J1V
NDC: 10742-8141
NDC: 10742-8141-1
NDC: 3107420107
RECALL-NUMBER: D-0722-2026
UPC: 0310742010749
UPC: 310742010749

Rohto Cooling Eye Drops Digi Eye (hypromellose 0

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

Quantity: 65219 cartons

Code or lot text: Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09

LOT: 4B1VA
LOT: 4J1V
LOT: Exp. Date 2027/01
LOT: Exp. Date 2027/09
LOT: Lot #: 4B1V
NDC: 10742-8175
NDC: 10742-8175-1
NDC: 3107420106
RECALL-NUMBER: D-0719-2026
UPC: 310742010602

Rohto Cooling Eye Drops Dry Aid (povidone 0

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

Quantity: 97201 cartons

Code or lot text: 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, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.

LOT: 4J1VA
LOT: 512V
LOT: 512VB 2028/11.
LOT: 512VB Exp. Date 2028/08
LOT: 5A1V
LOT: 5D1VA
LOT: 5G1VA
LOT: 5L2VA
LOT: Exp. Date 2027/06
LOT: Exp. Date 2027/09
LOT: Exp. Date 2027/12
LOT: Exp. Date 2028/03
LOT: Exp. Date 2028/06
LOT: Lot #: 4G1VA
NDC: 10742-8162
NDC: 10742-8162-1
NDC: 10742-8162-2
NDC: 3107420111
RECALL-NUMBER: D-0720-2026
UPC: 310742011135

Rohto Cooling Eye Drops Dry Aid (povidone 0

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

Quantity: 353 cartons

Code or lot text: Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08

LOT: 2028/03
LOT: 4J1V
LOT: 512V
LOT: 512VB 2027/09
LOT: 512VB 2028/06
LOT: 512VB 2028/08
LOT: 5D1V
LOT: 5G1V
LOT: Exp 2027/06
LOT: Lot #: 4G1V
NDC: 10742-8162
NDC: 10742-8162-1
NDC: 10742-8162-2
NDC: 3107420111
RECALL-NUMBER: D-0721-2026
UPC: 310742011159

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0

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

Quantity: 6076306 cartons

Code or lot text: 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.

LOT: 3H3V
LOT: 3J1V
LOT: 3J3V
LOT: 3J4V
LOT: 3J5V
LOT: 3K1V
LOT: 3K2V
LOT: 4A2V
LOT: 4B1V
LOT: 4B2V
LOT: 4B3V
LOT: 4F1V
LOT: 4F2V
LOT: 4F3V
LOT: 4F4V
LOT: 4G2V
LOT: 4G3V
LOT: 4G4V
LOT: 4G5V
LOT: 4H1V
LOT: 4I1V
LOT: 4I2V
LOT: 4I4V
LOT: 4I5V
LOT: Exp. Date 2026/07
LOT: Exp. Date 2026/09
LOT: Exp. Date 2026/10
LOT: Exp. Date 2026/12
LOT: Exp. Date 2027/01
LOT: Exp. Date 2027/05
LOT: Exp. Date 2027/06
LOT: Exp. Date 2027/07
LOT: Exp. Date 2027/08.
LOT: Lot #: 3H2V
NDC: 10742-8158
NDC: 10742-8158-1
NDC: 10742-8158-2
NDC: 3107420110
RECALL-NUMBER: D-0716-2026
UPC: 0310742011012
UPC: 310742011012

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0

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

Quantity: 499,673 cartons

Code or lot text: 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.

LOT: 3J2V
LOT: 4A1V
LOT: 4A1VA
LOT: 4G1V
LOT: 4I3V
LOT: 5A1V
LOT: 5B3V
LOT: 5G3V
LOT: 5J1V
LOT: 5L1V
LOT: 6A1V
LOT: 6B4V
LOT: 6C2V
LOT: Exp. Date 2026/09
LOT: Exp. Date 2026/12
LOT: Exp. Date 2027/06
LOT: Exp. Date 2027/08
LOT: Exp. Date 2027/12
LOT: Exp. Date 2028/06
LOT: Exp. Date 2028/09
LOT: Exp. Date 2028/11
LOT: Exp. Date 2028/12
LOT: Exp. Date 2029/01
LOT: Exp. Date 2029/02.
LOT: Exp. Date2026/07
LOT: Exp. Date2028/01
LOT: Lot #: 3H1V
NDC: 10742-8158
NDC: 10742-8158-1
NDC: 10742-8158-2
NDC: 3107420112
RECALL-NUMBER: D-0717-2026
UPC: 0310742011012
UPC: 310742011210

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0

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

Quantity: 1,278,457 cartons

Code or lot text: 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.

LOT: 3H1VA
LOT: 3J1V
LOT: 3J2V
LOT: 3K1V
LOT: 4F1V
LOT: 4F1VA
LOT: 4H1V
LOT: 4I1V
LOT: 4K1V
LOT: 4K2V
LOT: 5A1V
LOT: 5A2V
LOT: 5D1V
LOT: 5E1V
LOT: 5J1V
LOT: 5J2V
LOT: 6B1V
LOT: 6C1V
LOT: 6C1VA
LOT: 6C1VB
LOT: Exp. Date 2025/07
LOT: Exp. Date 2025/09
LOT: Exp. Date 2025/10
LOT: Exp. Date 2027/05
LOT: Exp. Date 2027/07
LOT: Exp. Date 2027/08
LOT: Exp. Date 2027/10
LOT: Exp. Date 2027/12
LOT: Exp. Date 2028/03
LOT: Exp. Date 2028/09
LOT: Exp. Date 2029/01
LOT: Exp. Date 2029/02.
LOT: Exp. Date2028/04
LOT: Lot #: 3H1V
NDC: 10742-8160
NDC: 10742-8160-1
NDC: 3107420109
RECALL-NUMBER: D-0718-2026
UPC: 0310742010916
UPC: 310742010916

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Lack of Assurance of Sterility

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked 8/16/2026, 6:17:24 AM UTC.

2026-08-16T06:17:24.928Zunchanged
2026-08-16T02:31:33.554Zcreated

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.