Asclemed Usa Inc.: FDA regulatory profile
Asclemed Usa Inc. appears in 4 indexed U.S. FDA records: 4 recall records, naming 4 distinct products. Latest dated event: a recall record dated 2026-07-29. Observations run 2026-06-10 to 2026-07-29 — 49 days, 4 dated records across 1 calendar year, busiest 2026 with 4. Recalls: 3 Class II (75%) and 1 Class III (25%); 4 ongoing by lifecycle status, reported 2026-06-10 to 2026-07-29; 4 with an FDA recall number, 4 with an initiation date, across 1 state, grouped into 3 FDA recall events. 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: Lidolog Kit (D-0713-2026, Class III, 2026-07-29), Accucaine (D-0658-2026, Class II, 2026-07-08), Lidocaine HCl Injection USP (D-0659-2026, Class II, 2026-07-08) and Duloxetine DR Capsules (D-0555-2026, Class II, 2026-06-10). Recalling-firm addresses are recorded in CA. Its recall lines are grouped by the FDA into 3 event identifiers: 99019, 99204 and 99408.
Regulatory snapshot
| Indexed records | 4 |
|---|---|
| Recall records | 4 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 4 |
| Recall classifications | Class II: 3 · Class III: 1 |
| Recall statuses | Ongoing: 4 |
| First observed | 2026-06-10 |
| Latest observed | 2026-07-29 |
| Latest event type | recall |
| Dated observations | 4 |
| Years covered | 1 |
| Span (days) | 49 |
| Busiest year | 2026 (4 records) |
| Recall states | 1 |
| With recall number | 4 of 4 |
| FDA recall events | 3 |
| 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 | 3 | 75% |
| Recall classification | Class III | 1 | 25% |
| Recall status | Ongoing | 4 | 100% |
Recall history (4)
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.
| Product (as published) | Recall number | Classification | Status | Reported | Initiated |
|---|---|---|---|---|---|
| Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use | D-0713-2026 | Class III | Ongoing | 2026-07-29 | 2026-07-15 |
| Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampu | D-0658-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-08 |
| Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed | D-0659-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-08 |
| Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceutica | D-0555-2026 | Class II | Ongoing | 2026-06-10 | 2026-05-14 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 99204 | 2 | Class II | 2026-07-08 | 2026-07-08 |
| 99019 | 1 | Class II | 2026-06-10 | 2026-06-10 |
| 99408 | 1 | Class III | 2026-07-29 | 2026-07-29 |
Browse the wider classification index: Class II recalls · Class III recalls.
Products and drugs named (4)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 | recall | 1 | 2026-07-08 |
| Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Eno | recall | 1 | 2026-06-10 |
| Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, R | recall | 1 | 2026-07-08 |
| Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial | recall | 1 | 2026-07-29 |
Source limitations
Built from the 4 ingested FDA records for this firm (4 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.