Amgen recalls Sensipar and Corlanor lots; BKEMV biosimilar gets label update
Amgen initiated five Class II drug recalls covering Sensipar and Corlanor tablets, and the FDA approved a supplement for its BKEMV eculizumab biosimilar.
Amgen's week centered on a cluster of voluntary recalls tied to manufacturing issues, alongside a routine regulatory update for one of its biosimilars.
- The FDA approved a supplement (SUPPL 8) for **BKEMV** (eculizumab-aeeb), an injectable treatment, with an approval letter dated July 2, 2026 and an updated label dated July 6, 20261.
- Amgen recalled 30mg Sensipar (cinacalcet) tablets due to CGMP deviations2, covering 9565 bottles distributed nationwide2, initiated June 4, 2026.
- Amgen also recalled 60mg and 90mg Sensipar (cinacalcet) tablets for the same reason, CGMP deviations3, both initiated June 4, 2026 and distributed nationwide.
- Corlanor (ivabradine) 5mg tablets were recalled for presence of foreign substance4, affecting 934,577 bottles4 distributed nationwide.
- Corlanor (ivabradine) 7.5mg tablets were recalled for the same reason, presence of foreign substance5, also initiated June 4, 2026 and distributed nationwide.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.