Recall: 49,488 Bottles of Cinacalcet Tablets Fail Dissolution Specifications; FDA Class II Recall Covers a Single Lot
The U.S. Food and Drug Administration's (FDA) Enforcement Report dated October 28 shows that Strides Pharma, Inc. has voluntarily recalled 49,488 bottles of cinacalcet tablets because the product failed dissolution specifications. The FDA classified the recall as Class II.
Cinacalcet is used to treat parathyroid hormone disorders in patients including those with chronic kidney disease. Only one lot is affected: cinacalcet tablets, 30 mg, lot 7717825A, expiring in November 2028.
Dissolution testing measures whether a tablet breaks down and releases its active ingredient at the intended rate so it can be absorbed. Tablets that fail dissolution specifications may not release the drug as designed, reducing the treatment's effectiveness.
Strides Pharma, based in Bridgewater, New Jersey, initiated the recall on October 7, 2026, and the FDA assigned the Class II classification on October 26. The company notified customers by letter and issued no separate press release.
A Class II classification means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote.
Pharmacies should check inventory, quarantine the affected lot and follow the company's instructions. Patients taking cinacalcet can check the lot number on their bottles and, if it matches, contact their pharmacy or prescriber about a replacement rather than stopping the medicine on their own.
FDA recalls and safety alerts page
Source: GSM · USA (original Chinese edition)
Photo: 处方药胶囊（资料图）。CC BY 2.0，经 Wikimedia Commons。 / Prescription capsules (file photo). CC BY 2.0, via Wikimedia Commons.
