Rohto-mentholatum (vietnam) Co., Ltd.: FDA regulatory profile
Rohto-mentholatum (vietnam) Co., Ltd. appears in 8 indexed U.S. FDA records: 8 recall records, naming 7 distinct products. Latest dated event: a recall record dated 2026-07-29. Observations run 2026-07-29 to 2026-07-29, 8 dated records across 1 calendar year, busiest 2026 with 8. Recalls: 8 Class II (100%); 8 ongoing by lifecycle status, reported 2026-07-29; 8 with an FDA recall number, 8 with an initiation date, across 1 state, grouped into 1 FDA recall event. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2% (D-0715-2026, Class II, 2026-07-29), Rohto Cooling Eye Drops Max Strength (naphazoline hydrochlor (D-0716-2026, Class II, 2026-07-29), Rohto Cooling Eye Drops Max Strength (naphazoline hydrochlor (D-0717-2026, Class II, 2026-07-29) and Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochlorid (D-0718-2026, Class II, 2026-07-29). Recalling-firm addresses are recorded in N/A.
Regulatory snapshot
| Indexed records | 8 |
|---|---|
| Recall records | 8 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 7 |
| Recall classifications | Class II: 8 |
| Recall statuses | Ongoing: 8 |
| First observed | 2026-07-29 |
| Latest observed | 2026-07-29 |
| Latest event type | recall |
| Dated observations | 8 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (8 records) |
| Recall states | 1 |
| With recall number | 8 of 8 |
| FDA recall events | 1 |
| Related firms / shortages | 0 / 0 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Recall classification | Class II | 8 | 100% |
| Recall status | Ongoing | 8 | 100% |
Recall history (8)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
Browse the wider classification index: Class II recalls.
Products and drugs named (7)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozolin | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3% | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3% | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, | recall | 1 | 2026-07-29 |
| Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, p | recall | 1 | 2026-07-29 |
Source limitations
Built from the 8 ingested FDA records for this firm (8 recall, 0 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.