Blaine Labs Inc: FDA regulatory profile
Blaine Labs Inc appears in 8 indexed U.S. FDA records: 8 recall records, naming 8 distinct products. Latest dated event: a recall record dated 2026-07-08. Observations run 2026-07-08 to 2026-07-08, 8 dated records across 1 calendar year, busiest 2026 with 8. Recalls: 1 Class I (13%) and 7 Class II (88%); 8 ongoing by lifecycle status, reported 2026-07-08; 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: Revitaderm Wound Care Gel (D-0692-2026, Class I, 2026-07-08), TRIFLUENT PHARMA TRIDERGEL Wound Care Gel (D-0693-2026, Class II, 2026-07-08), TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) (D-0694-2026, Class II, 2026-07-08) and TERPENICOL Antifungal Cream (Undecylenic Acid 13%) (D-0695-2026, Class II, 2026-07-08). Recalling-firm addresses are recorded in CA.
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 | 8 |
| Recall classifications | Class I: 1 · Class II: 7 |
| Recall statuses | Ongoing: 8 |
| First observed | 2026-07-08 |
| Latest observed | 2026-07-08 |
| 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 I | 1 | 13% |
| Recall classification | Class II | 7 | 88% |
| 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 I recalls · Class II recalls.
Products and drugs named (8)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Co | recall | 1 | 2026-07-08 |
| Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 | recall | 1 | 2026-07-08 |
| Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride | recall | 1 | 2026-07-08 |
| TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bott | recall | 1 | 2026-07-08 |
| TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%) | recall | 1 | 2026-07-08 |
| TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1% | recall | 1 | 2026-07-08 |
| TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (3 | recall | 1 | 2026-07-08 |
| vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle | recall | 1 | 2026-07-08 |
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.