FDA Drugs recall ·
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg… recall
- Recall number
- D-0542-2025
- Date
- (initiated July 2, 2025)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 7668 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot GB01616, expiration 2/28/2027
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0542-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.