Amlodipine Besylate And Benazepril Hydrochloride Capsule
FDA Recall NDC 68180-463
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 68180-463). 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 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
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
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
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.
