Cinacalcet Tablet, Film Coated
FDA Recall NDC 64380-883
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cinacalcet (NDC 64380-883). A significant event, classified as Class II, was initiated on Jul 09, 2025 by Strides Pharma Science Limited. The reported reason for this action was: "Failed Dissolution Specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications.
Jul 09, 2025
Aug 06, 2025
6,672 bottles
Recall Profile & Regulatory Data
Event ID
97215
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Strides Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States
Product Description
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Batch or Lot Expiration Information
Lot# : 7715893A, Exp. Date 12/31/2027
Affected Packages Involved in this Recall
64380-883-04Product
64380-884-04Product
64380-885-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
