Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactur...
FDA Recall #D-0542-2025 — Class II — July 2, 2025
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.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Recalling Firm
Lupin Pharmaceuticals Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7668 bottles
Distribution
Nationwide in the US
Code Information
Lot GB01616, expiration 2/28/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated