Lisinopril Tablet
FDA Recall NDC 0615-8253
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 0615-8253). A significant event, classified as Class III, was initiated on Oct 27, 2023 by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The reported reason for this action was: "Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots"
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
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Oct 27, 2023
Nov 29, 2023
12 cards
Recall Profile & Regulatory Data
Event ID
93336
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
NCS Healthcare of Kentucky Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Jul 14, 2024
Product Description
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
Batch or Lot Expiration Information
Lot# : a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024
Affected Packages Involved in this Recall
0615-7714-39Product
0615-7714-05Product
0615-7714-30Product
0615-7718-39Product
0615-7718-31Product
0615-7718-05Product
0615-7718-28Product
0615-7689-39Product
0615-7689-31Product
0615-7689-05Product
0615-8252-39Product
0615-8252-05Product
0615-8253-39Product
0615-8253-05Product
0615-8253-30Product
0615-8256-39Product
0615-8256-05Product
0615-8254-39Product
0615-8254-05Product
0615-8254-30Product
0615-8255-39Product
0615-8255-05Product
0615-8255-30Product
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.
