Keystone Industries: FDA regulatory profile
Keystone Industries appears in 7 indexed U.S. FDA records: 7 recall records, naming 7 distinct products. Latest dated event: a recall record dated 2026-06-24. Observations run 2026-06-24 to 2026-06-24, 7 dated records across 1 calendar year, busiest 2026 with 7. Recalls: 7 Class II (100%); 7 ongoing by lifecycle status, reported 2026-06-24; 7 with an FDA recall number, 7 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: Pearson Quality Topical Anesthetic Gel (20% Benzocaine) (D-0600-2026, Class II, 2026-06-24), Quala Dental Products (D-0601-2026, Class II, 2026-06-24), DHP Topical Anesthetic Gel (D-0602-2026, Class II, 2026-06-24) and Burkhart topical anesthetic gel (D-0603-2026, Class II, 2026-06-24). Recalling-firm addresses are recorded in NJ. Its recall lines are grouped by the FDA into 1 event identifier: 99076.
Regulatory snapshot
| Indexed records | 7 |
|---|---|
| Recall records | 7 |
| 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: 7 |
| Recall statuses | Ongoing: 7 |
| First observed | 2026-06-24 |
| Latest observed | 2026-06-24 |
| Latest event type | recall |
| Dated observations | 7 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (7 records) |
| Recall states | 1 |
| With recall number | 7 of 7 |
| 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 | 7 | 100% |
| Recall status | Ongoing | 7 | 100% |
Recall history (7)
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 |
|---|---|---|---|
| Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 | recall | 1 | 2026-06-24 |
| Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, | recall | 1 | 2026-06-24 |
| DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. ( | recall | 1 | 2026-06-24 |
| Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, | recall | 1 | 2026-06-24 |
| PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawbe | recall | 1 | 2026-06-24 |
| Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawb | recall | 1 | 2026-06-24 |
| safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Straw | recall | 1 | 2026-06-24 |
Source limitations
Built from the 7 ingested FDA records for this firm (7 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.