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Class II · ModerateActive recall

Amlodipine And Olmesartan Medoxomil

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

Does this affect you?
Check your lot numberLot 23121560, Exp 4/30/2026
Where it was soldNationwide in the USA
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

Failed Dissolution Specifications: low dissolution results

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 byAlkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 foreign manufacturer
Brand nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Generic nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Active ingredient(s)AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
Distributed by / forAscend Laboratories, LLC, Parsippany, NJ 07054
NDC67877-501-30
Show the full FDA record
Full product labelAmlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Recalling firmAscend Laboratories, LLC
DistributionNationwide in the USA
Quantity8,568 bottles
Recall initiated2025-07-21
Report date2025-08-20
Recall completed—
Recall numberD-0576-2025
ClassificationClass II
FDA statusOngoing
Origin on fileBedminster NJ 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.