Cinacalcet Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for cinacalcet tablets, 30 mg. The affected batch has been identified as Lot 7717825A (expiring November 2028), containing 49 488 bottles.
• The recall was initiated by Strides Pharma, Inc due to failed dissolution specifications, 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 tablets are used to treat hyperparathyroidism in patients with chronic kidney disease (CKD).

The FDA has issued a Class II recall for cinacalcet tablets, 30 mg, affecting 49 488 bottles. This product is being recalled by Strides Pharma, Inc based in Bridgewater, New Jersey. The recall was initiated on October 7, 2026, and received a Class II classification on October 26, 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 the product’s failure to meet dissolution specifications. This issue affects Lot 7717825A, which will expire in November 2028. Strides Pharma sent out a public notice via letter; no press release has been issued for this recall.

Cinacalcet tablets are used to treat hyperparathyroidism in patients with CKD who are on dialysis. They are also used to lower calcium levels in patients with parathyroid cancer and primary hyperparathyroidism. Pharmacists should identify and quarantine Lot 7717825A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 28, 2026. Accessed October 28, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223283