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

DimensionValueRecordsShare
Recall classificationClass II5100%
Recall statusOngoing5100%

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 numberClassificationStatusReportedInitiated
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.

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.

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.