Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recall
FDA recall D-0542-2025 · initiated Jul 2, 2025
Lupin Pharmaceuticals Inc. recalled Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg in Jul 2025 — an FDA Class II recall (D-0542-2025) because Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7668 bottles
Details
- 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.
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jul 2, 2025
- FDA report date
- Aug 6, 2025
Frequently asked
- Was Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalled?
- Lupin Pharmaceuticals Inc. recalled Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg in Jul 2025 — an FDA Class II recall (D-0542-2025) because Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0542-2025 was: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Is a recalled Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot GB01616, expiration 2/28/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0542-2025.