Lisinopril Tablet
FDA Recall NDC 68645-608
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 68645-608). A significant event, classified as Class II, was initiated on Nov 15, 2024 by Legacy Pharmaceutical Packaging, Llc. The reported reason for this action was: "Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet."
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 II Terminated
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Nov 15, 2024
Nov 27, 2024
222, 600 bottles
Recall Profile & Regulatory Data
Event ID
95749
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Evaric Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 23, 2026
Product Description
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90.
Batch or Lot Expiration Information
Lot# : 241103, exp. date 05/31/2026
Affected Packages Involved in this Recall
68645-609-90Product
68645-610-90Product
68645-611-90Product
68645-608-90Product
68645-612-90Product
68645-613-90Product
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.
