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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 25121311, expiry 3/31/2028
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; Olmesartan Medoxomil content below specifications

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., Parsnippany, 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., Parsnippany, NJ 07054
NDC67877-500-30
Show the full FDA record
Full product labelAmlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Recalling firmAscend Laboratories, LLC
DistributionNationwide in the USA
Quantity6,192 bottles
Recall initiated2026-07-08
Report date2026-07-29
Recall completed—
Recall numberD-0712-2026
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.