Lisinopril Tablet
FDA Recall NDC 65862-040
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 Lisinopril (NDC 65862-040). A significant event, classified as Class III, was initiated on Apr 09, 2013 by Aurobindo Pharma Limited. The reported reason for this action was: "Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Apr 09, 2013
Jun 05, 2013
1776 bottles
Recall Profile & Regulatory Data
Event ID
65071
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 23, 2014
Product Description
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Batch or Lot Expiration Information
Lot# Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
Affected Packages Involved in this Recall
65862-037-30Product
65862-037-01Product
65862-037-00Product
65862-037-05Product
65862-037-99Product
65862-038-30Product
65862-038-01Product
65862-038-00Product
65862-038-05Product
65862-038-99Product
65862-039-30Product
65862-039-01Product
65862-039-00Product
65862-039-05Product
65862-039-99Product
65862-040-30Product
65862-040-01Product
65862-040-00Product
65862-040-05Product
65862-040-99Product
65862-041-30Product
65862-041-01Product
65862-041-00Product
65862-041-05Product
65862-041-99Product
65862-042-30Product
65862-042-01Product
65862-042-00Product
65862-042-05Product
65862-042-99Product
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.
