Unrated Drug recall · FDA · Published July 14, 2026

Rohto Cooling Eye Drops Recall: Lack of Sterility Risk

Rohto recalls cooling eye drops due to lack of assurance of sterility. Products made in Vietnam with specific lot numbers and expiration dates are affected. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0722-2026Drug Rohto ›

Recall notice

Lack of Assurance of Sterility

✎ GovInfoNow plain-language explainer

Rohto is recalling its Cooling Eye Drops Cool Relief because they may not be sterile. This could lead to infections if used improperly. The recall affects specific lot numbers and expiration dates. Read more at govinfonow.com/recall/92414-rohto-cooling-eye-drops-recall-lack-of-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/92414-rohto-cooling-eye-drops-recall-lack-of-sterility-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0722-2026

Cite this page

“Rohto Cooling Eye Drops Recall: Lack of Sterility Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/92414-rohto-cooling-eye-drops-recall-lack-of-sterility-risk. Based on FDA recall #D-0722-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0722-2026%22&limit=1).

The FDA announced on July 14, 2026, that Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Cool Relief due to a lack of sterility assurance. Consumers should stop using the product immediately.

How to tell if you have it

Brand: Rohto
Product: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)
UPC: 310742010749
Lot codes: 3J1V, 4A1V, 4G1V, 4G2V, 4I1V, 4JIV, 5A1V, 5B1V, 5F1V, 5F1VA, 5H1V, 5H1VA, 5J1V, 5J1VA, 5L1V, 6B1V
Distribution: Nationwide within the United States

The hazard

The recall addresses a lack of assurance of sterility in the eye drops. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show other recent recalls of similar products include Clear Eyes Eye Drops Recall: Lack of Sterility Risk (2026-09-15), K.C. Pharmaceuticals Dry Eye Relief Eye Drops Recall: Lack of Sterility Assurance (2026-03-03), and K.C. Pharmaceuticals Ultra Lubricating Eye Drops Recall: Lack of Sterility Risk (2026-03-03).

How to tell if you have this one

Check the product label for the lot numbers listed: 3J1V, 4A1V, 4G1V, 4G2V, 4I1V, 4JIV, 5A1V, 5B1V, 5F1V, 5F1VA, 5H1V, 5H1VA, 5J1V, 5J1VA, 5L1V, 6B1V. The expiration dates range from 2026 to 2029.

Brand
Rohto
Product
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)
Category
Drug

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity
D-0715-2026	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; 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.	1.033,266 cartons
D-0716-2026	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; 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.	6076306 cartons
D-0717-2026	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; 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.	499,673 cartons
D-0718-2026	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; 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.	1,278,457 cartons
D-0719-2026	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; Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09	65219 cartons
D-0720-2026	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; 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.	97201 cartons
D-0721-2026	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; Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08	353 cartons
D-0722-2026	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; 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.	2910148 cartons

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot numbers listed in the recall notice: 3J1V, 4A1V, 4G1V, 4G2V, 4I1V, 4JIV, 5A1V, 5B1V, 5F1V, 5F1VA, 5H1V, 5H1VA, 5J1V, 5J1VA, 5L1V, 6B1V.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

Jul 14, 2026Firm started the recall
Jul 23, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/92414-rohto-cooling-eye-drops-recall-lack-of-sterility-risk">Rohto Cooling Eye Drops Recall: Lack of Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0722-2026 (July 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0722-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.