Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 70377-080
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 Atorvastatin Calcium (NDC 70377-080). A significant event, classified as Class II, was initiated on Mar 17, 2025 by Biocon Pharma Inc.. The reported reason for this action was: "Failed dissolution specifications: lower than 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: lower than specifications
Mar 17, 2025
Apr 09, 2025
2184 bottles
Recall Profile & Regulatory Data
Event ID
96496
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
BIOCON PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. nationwide
Product Description
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Batch or Lot Expiration Information
Lot# : AVC24035, Exp 03/31/26
Affected Packages Involved in this Recall
70377-077-11Product
70377-077-13Product
70377-077-12Product
70377-078-11Product
70377-078-13Product
70377-078-12Product
70377-079-11Product
70377-079-12Product
70377-079-13Product
70377-080-11Product
70377-080-12Product
70377-080-13Product
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.
