Amlodipine Besylate Tablet
FDA Recall NDC 68180-721
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Amlodipine Besylate (NDC 68180-721). A significant event, classified as Class III, was initiated on Jun 27, 2023 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Jun 27, 2023
Jul 19, 2023
3,096 bottles
Recall Profile & Regulatory Data
Event ID
92618
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Termination Date
Mar 12, 2024
Product Description
Amlodipine 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
Batch or Lot Expiration Information
Lot# : A102887, Exp. 6/2023
Affected Packages Involved in this Recall
68180-750-09Product
68180-751-09Product
68180-751-03Product
68180-751-17Product
68180-752-09Product
68180-752-03Product
68180-719-03Product
68180-719-09Product
68180-720-09Product
68180-720-03Product
68180-721-03Product
68180-721-09Product
68180-233-01Product
68180-233-02Product
68180-455-02Product
68180-455-01Product
Class III Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Feb 19, 2016
Sep 14, 2016
43,536 bottles
Recall Profile & Regulatory Data
Event ID
74964
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US No recalled product was distributed to any foreign consignees by Lupin.
Termination Date
Apr 03, 2017
Product Description
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Batch or Lot Expiration Information
Lot# : G304799, Exp. 4/2016
Affected Packages Involved in this Recall
68180-750-09Product
68180-751-09Product
68180-751-03Product
68180-751-17Product
68180-752-09Product
68180-752-03Product
68180-719-03Product
68180-719-09Product
68180-720-09Product
68180-720-03Product
68180-721-03Product
68180-721-09Product
68180-233-01Product
68180-233-02Product
68180-455-02Product
68180-455-01Product
Class III Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Feb 19, 2016
Sep 14, 2016
11,812 bottles
Recall Profile & Regulatory Data
Event ID
74964
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US No recalled product was distributed to any foreign consignees by Lupin.
Termination Date
Apr 03, 2017
Product Description
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Batch or Lot Expiration Information
Lot# : G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Affected Packages Involved in this Recall
68180-750-09Product
68180-751-09Product
68180-751-03Product
68180-751-17Product
68180-752-09Product
68180-752-03Product
68180-719-03Product
68180-719-09Product
68180-720-09Product
68180-720-03Product
68180-721-03Product
68180-721-09Product
68180-233-01Product
68180-233-02Product
68180-455-02Product
68180-455-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
