Amgen, Inc.: FDA regulatory profile
Amgen, Inc. appears in 5 indexed U.S. FDA records: 5 recall records, naming 5 distinct products. Latest dated event: a recall record dated 2026-07-01. Observations run 2026-07-01 to 2026-07-01, 5 dated records across 1 calendar year, busiest 2026 with 5. Recalls: 5 Class II (100%); 5 ongoing by lifecycle status, reported 2026-07-01; 5 with an FDA recall number, 5 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: Corlanor (ivabradine) tablets (D-0612-2026, Class II, 2026-07-01), Sensipar (cinacalcet) Tablets (D-0613-2026, Class II, 2026-07-01), Sensipar (cinacalcet) Tablets (D-0614-2026, Class II, 2026-07-01) and Corlanor (ivabradine) tablets (D-0615-2026, Class II, 2026-07-01). Recalling-firm addresses are recorded in CA. Its recall lines are grouped by the FDA into 1 event identifier: 99077. Distribution is recorded in the source as Nationwide within the United States.
Regulatory snapshot
| Indexed records | 5 |
|---|---|
| Recall records | 5 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 5 |
| Recall classifications | Class II: 5 |
| Recall statuses | Ongoing: 5 |
| First observed | 2026-07-01 |
| Latest observed | 2026-07-01 |
| Latest event type | recall |
| Dated observations | 5 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (5 records) |
| Recall states | 1 |
| With recall number | 5 of 5 |
| 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 | 5 | 100% |
| Recall status | Ongoing | 5 | 100% |
Recall history (5)
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 |
|---|---|---|---|---|---|
| Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), | D-0612-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-04 |
| Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One | D-0613-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-04 |
| Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One | D-0614-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-04 |
| Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks | D-0615-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-04 |
| Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One | D-0616-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-04 |
Browse the wider classification index: Class II recalls.
Products and drugs named (5)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles | recall | 1 | 2026-07-01 |
| Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen | recall | 1 | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distri | recall | 1 | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distri | recall | 1 | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distri | recall | 1 | 2026-07-01 |
Source limitations
Built from the 5 ingested FDA records for this firm (5 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.