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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 #: A102887, Exp. 6/2023
Where it was soldProduct was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
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

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

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 byLupin Limited, Aurangabad 431 210 India foreign manufacturer
Brand nameAMLODIPINE BESYLATE
Generic nameAMLODIPINE BESYLATE
Active ingredient(s)AMLODIPINE BESYLATE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S
NDC68180-721-03
Show the full FDA record
Full product labelAmlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Quantity3,096 bottles
Recall initiated2023-06-27
Report date2023-07-19
Recall completed2024-03-12
Recall numberD-0899-2023
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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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.