Ascend Laboratories, LLC: FDA regulatory profile
Ascend Laboratories, LLC appears in 9 indexed U.S. FDA records: 9 recall records, naming 9 distinct products. Latest dated event: a recall record dated 2026-08-05. Observations run 2026-05-20 to 2026-08-05 — 77 days, 9 dated records across 1 calendar year, busiest 2026 with 9. Recalls: 4 Class II (44%) and 5 Class III (56%); 9 ongoing by lifecycle status, reported 2026-05-20 to 2026-08-05; 9 with an FDA recall number, 9 with an initiation date, across 1 state, grouped into 6 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: Dabigatran Etexilate Capsules (D-0737-2026, Class III, 2026-08-05), Dabigatran Etexilate Capsules (D-0738-2026, Class III, 2026-08-05), Dabigatran Etexilate Capsules (D-0739-2026, Class III, 2026-08-05) and Amlodipine and Olmesartan Medoxomil Tablets (D-0712-2026, Class II, 2026-07-29). Recalling-firm addresses are recorded in NJ. Its recall lines are grouped by the FDA into 6 event identifiers: 98821, 98874, 99129, 99330 and 99385, and 1 further entry.
Regulatory snapshot
| Indexed records | 9 |
|---|---|
| Recall records | 9 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 9 |
| Recall classifications | Class II: 4 · Class III: 5 |
| Recall statuses | Ongoing: 9 |
| First observed | 2026-05-20 |
| Latest observed | 2026-08-05 |
| Latest event type | recall |
| Dated observations | 9 |
| Years covered | 1 |
| Span (days) | 77 |
| Busiest year | 2026 (9 records) |
| Recall states | 1 |
| With recall number | 9 of 9 |
| FDA recall events | 6 |
| 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 | 4 | 44% |
| Recall classification | Class III | 5 | 56% |
| Recall status | Ongoing | 9 | 100% |
Recall history (9)
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.
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 99421 | 3 | Class III | 2026-08-05 | 2026-08-05 |
| 99330 | 2 | Class III | 2026-07-29 | 2026-07-29 |
| 98821 | 1 | Class II | 2026-05-20 | 2026-05-20 |
| 98874 | 1 | Class II | 2026-06-10 | 2026-06-10 |
| 99129 | 1 | Class II | 2026-06-17 | 2026-06-17 |
| 99385 | 1 | Class II | 2026-07-29 | 2026-07-29 |
Browse the wider classification index: Class II recalls · Class III recalls.
Products and drugs named (9)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets p | recall | 1 | 2026-07-29 |
| Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-cou | recall | 1 | 2026-06-10 |
| Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablet | recall | 1 | 2026-05-20 |
| Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only | recall | 1 | 2026-07-29 |
| Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only | recall | 1 | 2026-07-29 |
| Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack fu | recall | 1 | 2026-08-05 |
| Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack fur | recall | 1 | 2026-08-05 |
| Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack furt | recall | 1 | 2026-08-05 |
| Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-co | recall | 1 | 2026-06-17 |
Source limitations
Built from the 9 ingested FDA records for this firm (9 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.