Rohto Cooling Eye Drops Max Strength, 0.03% recall — Rohto-mentholatum (vietnam) Co., Ltd. (Class II)
Rohto-mentholatum (vietnam) Co., Ltd. is recorded by the U.S. Food and Drug Administration (FDA) as recalling Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%) — a Class II recall, initiated 2026-07-14 and posted to the FDA enforcement report on 2026-07-29, under recall number D-0717-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Lack of Assurance of Sterility”. From the product description, the form is eye drops, the strengths given are 0.03%, 0.2% and 13 mL and the package is described as TWIN PACK and 0.4 FL OZ (13 mL). 1 National Drug Code number is printed in the record: 10742-8158-2, alongside UPC 310742011210. Distribution is recorded as “Nationwide within the United States” — Nationwide (US), with the recalling firm on record in N/A, Vietnam. The FDA files it under event ID 99440 together with 7 other recall numbers, all listed and linked below. Within that event this is the strength 0.03% · 0.2% · 13 mL, package TWIN PACK · 0.4 FL OZ (13 mL) and ndc 10742-8158-2 configuration; the sibling records differ on strength, package, ndc and product named and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0717-2026 |
|---|---|
| FDA event ID | 99440 (8 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Rohto-mentholatum (vietnam) Co., Ltd. |
| Recall initiated | 2026-07-14 |
| Reported by FDA | 2026-07-29 |
| Report lag | 15 days from initiation to report |
| Distribution | Nationwide within the United States — Nationwide (US) |
| Firm location on record | N/A, Vietnam |
| Product description (source) | 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 |
Reason reported by FDA
Lack of Assurance of Sterility
5 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
10 identifying values matched by exact pattern in the 36-word product description above; each is a literal substring of it.
| Product named | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%) |
|---|---|
| Form | Eye Drops |
| Strength | 0.03% · 0.2% · 13 mL |
| Package | TWIN PACK · 0.4 FL OZ (13 mL) |
| NDC | 10742-8158-2 |
| UPC | 310742011210 |
| Stated origin | Vietnam |
| Distributed by | The Mentholatum Company, Orchard Park |
Which configuration this record is
8 recall numbers share event 99440. They differ on strength, package, ndc and product named and agree on everything else the source states, so those are the values to check a package against.
Shared across all 8 records under this event: form Eye Drops; fda tier Class II; recalling firm Rohto-mentholatum (vietnam) Co., Ltd.; reason text Lack of Assurance of Sterility; initiated 2026-07-14; reported 2026-07-29.
Event context: 8 recall numbers under event 99440
One enforcement action, 8 recall numbers: the FDA filed 7 further configurations of this action under event 99440. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| Rohto Cooling Eye Drops ALL-IN-ONE, 0.2% | D-0715-2026 | Class II | 0.2% · Eye Drops | 10742-8146-1 | 2026-07-29 |
| Rohto Cooling Eye Drops Max Strength, 0.03% | D-0716-2026 | Class II | 0.03% · Eye Drops | 10742-8158-1 | 2026-07-29 |
| Rohto Cooling Eye Drops Optic Glow, 0.03% | D-0718-2026 | Class II | 0.03% · Eye Drops | 10742-8160-1 | 2026-07-29 |
| Rohto Cooling Eye Drops Digi Eye, 0.35% | D-0719-2026 | Class II | 0.35% · Eye Drops | 10742-8175-1 | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%) | D-0720-2026 | Class II | 0.68% · Eye Drops | 10742-8162-1 | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%) | D-0721-2026 | Class II | 0.68% · Eye Drops | 10742-8162-2 | 2026-07-29 |
| Rohto Cooling Eye Drops Cool Relief, 0.012% | D-0722-2026 | Class II | 0.012% · Eye Drops | 10742-8141-1 | 2026-07-29 |
Reported in the same month (2026-07)
111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Levothyroxine Sodium Tablets, 25 mcg | D-0700-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 50 mcg | D-0701-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 75 mcg | D-0702-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 88 mcg | D-0703-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 112 mcg | D-0704-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 125 mcg | D-0705-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 150 mcg | D-0706-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
| Levothyroxine Sodium Tablets, 25 mcg | D-0707-2026 | Major Pharmaceuticals | Class II | 2026-07-29 |
Nearest Class II recalls by date
213 of 250 indexed records share the Class II tier; the 1 nearest to 2026-07-29 by report date are listed here.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| Levothyroxine Sodium Tablets, 50 mcg | D-0708-2026 | Major Pharmaceuticals | 50 mcg · Tablets | 2026-07-29 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99440 returns all 8 of these recall numbers; a search on D-0717-2026 returns only this configuration. Match a package against 10742-8158-2 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Rohto-mentholatum (vietnam) Co., Ltd. (8 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0717-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0717-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-07-29
- Ingested
- 2026-08-22
- Record hash
56f98c122eaef17d
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.