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Class II · ModerateRecall completed

Amlodipine And Olmesartan Medoxomil

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

Does this affect you?
Check your lot numberLot#: BAD62101A, Exp 2/2024
Where it was soldUSA Nationwide
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

cGMP deviations

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 byMacleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA foreign manufacturer
Brand nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Generic nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Active ingredient(s)AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
Distributed by / forMacleods Pharma USA, Inc., Plainsboro, NJ 08536
NDC33342-192-07
Show the full FDA record
Full product labelAmlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
Recalling firmMacleods Pharma Usa Inc
DistributionUSA Nationwide
Quantity3,672 bottles
Recall initiated2022-02-15
Report date2022-03-09
Recall completed2023-02-17
Recall numberD-0632-2022
ClassificationClass II
FDA statusTerminated
Origin on filePlainsboro 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.