AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Recalling Firm / Manufacturer: Lupin Pharmaceuticals Inc.
(Naples, FL, United States)
FDA Recall Number: D-0542-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Generic Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Active Substance(s)
Amlodipine Besylate, Benazepril Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
68180-459
Total Quantity Recalled
7668 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Completed
FDA Enforcement Report Date
August 06, 2025
Firm Initiation Date
July 02, 2025
FDA Classification Date
Jul 28, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot GB01616, expiration 2/28/2027
Distribution Information
Geographic scope of affected shipments
Nationwide in the US
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0542-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC