Cinacalcet Tablets Recalled Due to CGMP Deviations

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for sensipar (cinacalcet) tablets, 30 mg. The affected batch has been identified as Lot 1156858 (expires December 2027), affecting 9565 bottles.
• The recall was initiated by Amgen, Inc due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease. It can also be used to lower calcium levels in the blood.

The FDA has issued a Class II recall for sensipar (cinacalcet) tablets, 30 mg, affecting 9565 bottles. This medication is being recalled by Amgen, Inc based in Thousand Oakes, California. The recall was initiated on June 4, 2026, and received a Class II classification on June 23, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to CGMP deviations. This deficiency affects Lot 1156858, which will expire in December 2027. Amgen, Inc sent out a public notice via letter; no press release has been issued for this recall.

Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis. It is also used to lower calcium levels in patients with parathyroid cancer and primary hyperparathyroidism. Pharmacists should identify and quarantine Lot 1156858, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 1, 2026. Accessed July 1, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220748