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Class III · Lower riskRecall completed

Amlodipine Besylate

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

Does this affect you?
Check your lot numberLot #: 6142626, Exp 09/19
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

PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

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., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645 foreign manufacturer
Brand nameAMLODIPINE BESYLATE
Generic nameAMLODIPINE BESYLATE
Active ingredient(s)AMLODIPINE BESYLATE
Distributed by / forAscend Laboratories, LLC Montvale, NJ 07645
NDC67877-199-10
Show the full FDA record
Full product labelAMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
Recalling firmAscend Laboratories LLC
DistributionNationwide in the USA.
Quantity1212 bottles
Recall initiated2017-05-05
Report date2017-09-20
Recall completed2018-04-25
Recall numberD-1134-2017
ClassificationClass III
FDA statusTerminated
Origin on fileMontvale 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.