FDAClass IIAugust 6, 2025

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recall: Labeling Error

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL…

Why was Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot GB01616, expiration 2/28/2027

Product
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
7668 bottles
Distribution
Nationwide in the US
Recall date
August 6, 2025
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls