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Class III · Lower riskRecall completed

Amlodipine And Olmesartan Medoxomil

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: OWSA18002-A, Exp 7/2020
Where it was soldU.S.A. 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

Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).

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 byMade in India foreign manufacturer
Brand nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Generic nameAMLODIPINE AND OLMESARTAN MEDOXOMIL
Active ingredient(s)AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852
NDC65862-855-30
Show the full FDA record
Full product labelAmlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Recalling firmAurobindo Pharma USA Inc.
DistributionU.S.A. Nationwide
Quantity4464 bottles
Recall initiated2018-11-30
Report date2018-12-12
Recall completed2022-02-01
Recall numberD-0289-2019
ClassificationClass III
FDA statusTerminated
Origin on fileEast Windsor 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.