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Class II · ModerateActive recall

Amlodipine Besylate And Benazepril Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot GB01616, expiration 2/28/2027
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Goa 103 722, INDIA foreign manufacturer
Brand nameAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Generic nameAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Active ingredient(s)AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc., Naples, FL, 34108, United States
NDC68180-755-01
Show the full FDA record
Full product labelAmlodipine 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 firmLupin Pharmaceuticals Inc.
DistributionNationwide in the US
Quantity7668 bottles
Recall initiated2025-07-02
Report date2025-08-06
Recall completed—
Recall numberD-0542-2025
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL United States

Related

Amlodipine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.