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Drug FDA Class II Ongoing Mislabeling

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.

Lupin Pharmaceuticals Inc. Published Aug 6, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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.

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE · 7668 bottles

NDC: 68180-459, 68180-755, 68180-756, 68180-472, 68180-463, 68180-473, 68180-759, 68180-760, 68180-757, 68180-758, 68180-755-01, 68180-755-02, 68180-755-03, 68180-756-01, 68180-756-02, 68180-756-03, 68180-459-01, 68180-459-02, 68180-459-03, 68180-472-01, 68180-472-02, 68180-472-03, 68180-463-01, 68180-463-02, 68180-463-03, 68180-473-01, 68180-473-02, 68180-473-03, 68180-759-01, 68180-759-02, 68180-759-03, 68180-760-01, 68180-760-02, 68180-760-03, 68180-757-01, 68180-757-02, 68180-757-03, 68180-758-01, 68180-758-02, 68180-758-03
Lot codes: GB01616
Code info: Lot GB01616, expiration 2/28/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 2, 2025
  2. Published
    Aug 6, 2025
Recall number
D-0542-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.