Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% recall
FDA recall D-0722-2026 · initiated Jul 14, 2026
Rohto-Mentholatum (Vietnam) Co., Ltd. recalled Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% in Jul 2026 — an FDA Class II recall (D-0722-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2910148 cartons
Details
- Product
- 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
- Recalling company
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jul 14, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% recalled?
- Rohto-Mentholatum (Vietnam) Co., Ltd. recalled Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% in Jul 2026 — an FDA Class II recall (D-0722-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% recalled?
- Per the FDA enforcement record, the reason for recall D-0722-2026 was: Lack of Assurance of Sterility
- Is a recalled Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012% are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — 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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0722-2026.