Amlodipine Besylate And Benazepril Hydrochloride Capsule
FDA Recall NDC 68180-459
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 Amlodipine Besylate And Benazepril Hydrochloride (NDC 68180-459). A significant event, classified as Class II, was initiated on Jul 02, 2025 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027"
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
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Jul 02, 2025
Aug 06, 2025
7668 bottles
Recall Profile & Regulatory Data
Event ID
97182
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Jul 30, 2026
Product Description
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Batch or Lot Expiration Information
Lot# Lot GB01616, expiration 2/28/2027
Affected Packages Involved in this Recall
68180-755-01Product
68180-755-02Product
68180-755-03Product
68180-756-01Product
68180-756-02Product
68180-756-03Product
68180-459-01Product
68180-459-02Product
68180-459-03Product
68180-472-01Product
68180-472-02Product
68180-472-03Product
68180-463-01Product
68180-463-02Product
68180-463-03Product
68180-473-01Product
68180-473-02Product
68180-473-03Product
68180-759-01Product
68180-759-02Product
68180-759-03Product
68180-760-01Product
68180-760-02Product
68180-760-03Product
68180-757-01Product
68180-757-02Product
68180-757-03Product
68180-758-01Product
68180-758-02Product
68180-758-03Product
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.
