Rosuvastatin Tablet, Film Coated
FDA Recall NDC 50268-710
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 Rosuvastatin (NDC 50268-710). A significant event, classified as Class II, was initiated on Dec 31, 2025 by Avpak. The reported reason for this action was: "Out of specification for dissolution."
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
Out of specification for dissolution.
Dec 31, 2025
Jan 14, 2026
7,991 5x10 cartons
Recall Profile & Regulatory Data
Event ID
98246
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Batch or Lot Expiration Information
Lot# 49124, Exp Date 12/31/2026
Affected Packages Involved in this Recall
50268-709-11Product
50268-709-15Product
50268-710-11Product
50268-710-15Product
50268-711-11Product
50268-711-15Product
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.
